MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-03-23 for TRIPLE LUMEN CATHETER UNK manufactured by Abbott Critical Care Systems.
[17104837]
Triple lumen catheter was placed in the o. R. While assessing pt in the critical care unit 4 days later, discovered the port/hub was broken off. Unfortunately ports were discarded upon removal the next day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 323256 |
| MDR Report Key | 323256 |
| Date Received | 2001-03-23 |
| Date of Report | 2001-02-06 |
| Date of Event | 2001-01-12 |
| Date Facility Aware | 2001-01-13 |
| Report Date | 2001-02-06 |
| Date Reported to Mfgr | 2001-01-16 |
| Date Added to Maude | 2001-04-02 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | TRIPLE LUMEN CATHETER |
| Generic Name | TRIPLE LUMEN CATHETER |
| Product Code | GBP |
| Date Received | 2001-03-23 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 312726 |
| Manufacturer | ABBOTT CRITICAL CARE SYSTEMS |
| Manufacturer Address | 2000 REGENCY PARKWAY SUITE 270 CARY NC 27511 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-03-23 |