MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-18 for ARROW INTERNATIONAL CDC-05052-HPKIA manufactured by Picc Kit 5 French.
[1288943]
Placement of picc line by usual method. Placement was confirmed by x-ray. When pulling the wire out, resistance was noted. The wire could not be removed. The picc line was discontinued due to this problem. The covering of the wire was noted to be unraveling when the line was pulled. The offending wire has been saved and is available for examination. The patient was rescheduled for picc line placement. This will extend her hospital stay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015225 |
| MDR Report Key | 1638198 |
| Date Received | 2010-03-18 |
| Date of Report | 2010-03-18 |
| Date of Event | 2010-03-17 |
| Date Added to Maude | 2010-03-26 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW INTERNATIONAL |
| Generic Name | PRESSURE INJECTABLE PICC KIT WITH BLUE FLEX TIP CATHETER AND PLACEMENT WIRE |
| Product Code | OMF |
| Date Received | 2010-03-18 |
| Model Number | CDC-05052-HPKIA |
| Catalog Number | CDC-05052-HPKIA |
| Lot Number | RF0018012 |
| Device Expiration Date | 2011-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PICC KIT 5 FRENCH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-03-18 |