MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-05 for 12 FR 3 LUMEN 16 CM CATHETER AK12123F manufactured by Arrow.
[14707]
Triple lumen catheter placed in right femoral vein for dialysis. Pt pulled at catheter and the piggy back port came out. Pt bled, catheter removed. Pt is ok.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 22439 |
| MDR Report Key | 22439 |
| Date Received | 1995-05-05 |
| Date of Report | 1995-04-27 |
| Date of Event | 1995-04-27 |
| Date Added to Maude | 1995-06-14 |
| 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 | 12 FR 3 LUMEN 16 CM CATHETER |
| Generic Name | CATHETER |
| Product Code | LFK |
| Date Received | 1995-05-05 |
| Catalog Number | AK12123F |
| Lot Number | AK-1-044-5 |
| Device Expiration Date | 1997-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 22606 |
| Manufacturer | ARROW |
| Manufacturer Address | READING PA 19605 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-05-05 |