MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-22 for DESILET CATHETER SELDINGER TECHNIQUE 8113008A manufactured by Vygon Corp..
[7023]
Small blood leak from the arterial catheter during cavh dialysis. Site inspected and small pinhole opening noted. No injury to pt. Catheter replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001696 |
| MDR Report Key | 12897 |
| Date Received | 1994-04-22 |
| Date of Report | 1994-04-15 |
| Date of Event | 1994-04-07 |
| Date Added to Maude | 1994-04-25 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DESILET CATHETER SELDINGER TECHNIQUE |
| Product Code | FIQ |
| Date Received | 1994-04-22 |
| Catalog Number | 8113008A |
| Lot Number | 060593EN2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 12895 |
| Manufacturer | VYGON CORP. |
| Manufacturer Address | E RUTHERFORD NJ 07073 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-04-22 |