MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-04-12 for MEDEX? DOUBLE Y-CONNECTOR MX612-HRV manufactured by Smiths Medical Asd, Inc..
[72659548]
Smiths medical has received the sample device. A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.
Patient Sequence No: 1, Text Type: N, H10
[72659549]
It was reported that a medex? Double y-connector was attached to a patient in the intensive care unit for a noradrenaline infusion when it was observed that the check valve started to leak within 24 hours of use. It was noted that forceps were used to disconnect the infusion and the extension, which caused the bonding material to loosen and disintegrate. No patient injury was reported. See mfr: 3012307300-2017-00834.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2017-00901 |
| MDR Report Key | 6487541 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-04-12 |
| Date of Report | 2017-09-14 |
| Date Mfgr Received | 2017-08-29 |
| Date Added to Maude | 2017-04-12 |
| 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 | LISA PERZ |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833074 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD |
| Manufacturer Street | UNIT 4 BRADWOOD COURT ST. 1 CRISPIN WAY |
| Manufacturer City | ROSSENDALE, BB4 4PW |
| Manufacturer Country | UK |
| Manufacturer Postal Code | BB4 4PW |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDEX? DOUBLE Y-CONNECTOR |
| Generic Name | TUBING, FLUID DELIVERY |
| Product Code | FPK |
| Date Received | 2017-04-12 |
| Returned To Mfg | 2017-04-10 |
| Catalog Number | MX612-HRV |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-12 |