MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 1997-07-25 for V-CATH 360-45 OR 380-45 NA manufactured by Hdc Corp..
[78263]
Catheter broke at the hub. Catheter was removed via a cutdown method. Pt is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2925153-1997-00008 |
| MDR Report Key | 107869 |
| Report Source | 04,05,06 |
| Date Received | 1997-07-25 |
| Date of Report | 1997-07-21 |
| Date Mfgr Received | 1997-06-21 |
| Date Added to Maude | 1997-07-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | V-CATH |
| Generic Name | PICC |
| Product Code | HDC |
| Date Received | 1997-07-25 |
| Model Number | 360-45 OR 380-45 |
| Catalog Number | NA |
| Lot Number | 1069 1038 OR 1069 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 106019 |
| Manufacturer | HDC CORP. |
| Manufacturer Address | 2109 O'TOOLE AVE. SAN JOSE CA 95131 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1997-07-25 |