MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-21 for BARON SUCT TUBE 3 ANG 3FR 385080 manufactured by Integra York, Pa Inc..
[41047379]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[41047380]
Dealer initially reports this instrument has been broken from the root (at the curve) during e. N. T surgery in direct contact with patient under normal conditions and there are no broken parts inside the patient. On 3/11/2016 no further information available.
Patient Sequence No: 1, Text Type: D, B5
[48203506]
On 06/06/2016 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - failure analysis cannot be performed based on the lack of information provided by the customer. No device returned for further evaluation. Device history evaluation - dhr review was completed with all history available. Nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: none. Corrective action preventive action history: none. Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation. Instrument was not returned.
Patient Sequence No: 1, Text Type: N, H10
[60927441]
On (b)(6) 2016 integra investigation completed. Failure analysis, device history evaluation. Failure analysis - a suction tube returned in used condition, not showing any unusual markings the suction tube shows wear, bent stylet and broken shaft. During the visual inspection of the instrument, it is noticed that the stylet is bent and the shaft is broken. Without knowing how much pressure was used to the tube, the cause is undetermined. The complaint is confirmed. Device history evaluation - dhr review was completed with all history available the root cause has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2016-00034 |
| MDR Report Key | 5513332 |
| Date Received | 2016-03-21 |
| Date of Report | 2016-03-09 |
| Date Mfgr Received | 2016-11-08 |
| Date Added to Maude | 2016-03-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARON SUCT TUBE 3 ANG 3FR |
| Generic Name | N/A |
| Product Code | JZF |
| Date Received | 2016-03-21 |
| Returned To Mfg | 2016-10-28 |
| Catalog Number | 385080 |
| Lot Number | 8859113 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-21 |