MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-31 for HICKMAN SUBCUTANEOUS PORT 8120696SS manufactured by Davol, Inc. - Subsidiary Of C.r. Bard, Inc..
[4595]
Patient had right subclavian mediport placed 4/18/89. Patient had no problems with mediport prior to 8/23/93. Upon attempting to flush catheter, resistance was met. A chest x-ray was ordered and it was discovered that mediport was fractured. Device was removed and replaced with new mediportdevice labeled for single use. Patient medical status prior to event: satisfactory condition. 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: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service, device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6453 |
| MDR Report Key | 6453 |
| Date Received | 1993-08-31 |
| Date of Report | 1993-08-25 |
| Date of Event | 1993-08-23 |
| Date Facility Aware | 1993-08-23 |
| Report Date | 1993-08-25 |
| Date Reported to FDA | 1993-08-25 |
| Date Reported to Mfgr | 1993-08-25 |
| Date Added to Maude | 1993-09-15 |
| 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 | HICKMAN SUBCUTANEOUS PORT |
| Generic Name | MEDIPORT |
| Product Code | LLD |
| Date Received | 1993-08-31 |
| Model Number | 8120696SS |
| Lot Number | 41L8DK06 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 6142 |
| Manufacturer | DAVOL, INC. - SUBSIDIARY OF C.R. BARD, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-08-31 |