MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for PHARMACIA manufactured by Pharmacia-deltec.
[5427]
Iv therapy nurse found patient's picc line broken at hub. Catheter tubing open to air. No bleeding from catheter. Iv therapy nurse removed catheter from patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17971 |
| MDR Report Key | 17971 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-06-06 |
| Date of Event | 1994-04-16 |
| Date Added to Maude | 1994-11-28 |
| 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 | PHARMACIA |
| Generic Name | DOUBLE LUMEN PICC - L - CATH |
| Product Code | FGH |
| Date Received | 1994-07-29 |
| Returned To Mfg | 1994-06-06 |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17884 |
| Manufacturer | PHARMACIA-DELTEC |
| Manufacturer Address | 1265 GREY FOX ROAD ST. PAUL MN 55112 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-29 |