MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-09 for PERMCATH PDLC5519 manufactured by Vas-cath, Inc..
[20055476]
Perm catheter broke during hemodialysis with arterial hub of catheter seperating from remainder of perminate catheter causing blood loss and possible infectiondevice labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: telemetry failure, hub. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service, device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5441 |
| MDR Report Key | 5441 |
| Date Received | 1993-04-09 |
| Date of Report | 1993-03-10 |
| Date of Event | 1993-03-02 |
| Date Facility Aware | 1993-03-02 |
| Report Date | 1993-03-10 |
| Date Reported to Mfgr | 1993-03-10 |
| Date Added to Maude | 1993-07-13 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERMCATH |
| Generic Name | HEMODIALYSIS CATHETER |
| Product Code | FJT |
| Date Received | 1993-04-09 |
| Catalog Number | PDLC5519 |
| Lot Number | 169-075 |
| ID Number | 19CM, SOFT CELL |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 5137 |
| Manufacturer | VAS-CATH, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-04-09 |