MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 1996-09-09 for NEFF INFRARENAL AORTOILIAC CATHETER HNBR5.0-35-80-PW-6S-NEFF-04269 manufactured by Cook Incorporated.
[25318]
Device was introduced and an injection performed. Upon attempted removal, the catheter tip separated. A retrieval device was utilized for removal of the separated segment. Pt has not sustained any adverse effect from this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-1996-00003 |
| MDR Report Key | 36908 |
| Report Source | 01,05 |
| Date Received | 1996-09-09 |
| Date of Report | 1996-08-13 |
| Date Facility Aware | 1996-07-26 |
| Date Mfgr Received | 1996-08-13 |
| Device Manufacturer Date | 1996-05-01 |
| Date Added to Maude | 1996-09-10 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEFF INFRARENAL AORTOILIAC CATHETER |
| Generic Name | CATHETER |
| Product Code | LFK |
| Date Received | 1996-09-09 |
| Model Number | NA |
| Catalog Number | HNBR5.0-35-80-PW-6S-NEFF-04269 |
| Lot Number | F81911 |
| ID Number | NA |
| Device Expiration Date | 1999-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 38293 |
| Manufacturer | COOK INCORPORATED |
| Manufacturer Address | 925 SOUTH CURRY PIKE BLOOMINGTON IN 47402 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-09-09 |