MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2005-12-23 for ALGOLINE CATHETER KIT 81102 manufactured by Medtronic Neurosurgery.
[425651]
It was reported that the tip of the catheter was broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2005-00235 |
| MDR Report Key | 657404 |
| Report Source | 05,07 |
| Date Received | 2005-12-23 |
| Date of Report | 2005-11-28 |
| Date Mfgr Received | 2005-12-05 |
| Date Added to Maude | 2005-12-30 |
| 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 | JEFFREY HENDERSON |
| Manufacturer Street | 125 CREMONA DR |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8059681546 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DR |
| Manufacturer City | GOLETA CA 93117550 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93117 5500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALGOLINE CATHETER KIT |
| Generic Name | CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT |
| Product Code | MAJ |
| Date Received | 2005-12-23 |
| Returned To Mfg | 2005-12-05 |
| Model Number | NA |
| Catalog Number | 81102 |
| Lot Number | A65194 |
| ID Number | NA |
| Device Expiration Date | 2010-03-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNK |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 646892 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DR. GOLETA CA 931175500 US |
| Baseline Brand Name | ALGOLINE CATHETER KIT, CLOSED TIP CATHETER |
| Baseline Generic Name | CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT-TERM |
| Baseline Model No | NA |
| Baseline Catalog No | 81102 |
| Baseline ID | NA |
| Baseline Device Family | ALGOLINE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K911382 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-12-23 |