MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for COOK CATHETER manufactured by Cook, Inc..
[10262]
Double lumen cook catheter per central venous line found broken into. The break in tubing involved both tubes near the distal ports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17543 |
| MDR Report Key | 17543 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-06-30 |
| Date of Event | 1994-06-18 |
| Date Facility Aware | 1994-06-20 |
| Report Date | 1994-06-30 |
| Date Added to Maude | 1994-11-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK CATHETER |
| Generic Name | COOK CATHETER |
| Product Code | FGH |
| Date Received | 1994-07-29 |
| Lot Number | 389954 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 17464 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | P.O. BOX 489 BLOOMINGTON IN 47402 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1994-07-29 |