MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for A.V. FISTULA SET 5M0564 manufactured by Baxter Healthcare Corporation.
[5366]
At the end of dialysis, needles were being pulled & it was noted that the venous needle had separated. The needle had separated from the catheter & needle was still in graft. Nurses held pressure for 25 minutes till they saw an end of needle which they were able to use forcepts & remove from graft. X-ray done 01/22/94 to locate needle in graft. Device 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. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9069 |
| MDR Report Key | 9069 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-02-16 |
| Date of Event | 1994-01-22 |
| Date Facility Aware | 1994-01-22 |
| Report Date | 1994-02-16 |
| Date Reported to Mfgr | 1994-01-24 |
| Date Added to Maude | 1994-11-23 |
| 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 | A.V. FISTULA SET |
| Generic Name | NEEDLES, DIALYSIS |
| Product Code | LBW |
| Date Received | 1994-07-29 |
| Model Number | NA |
| Catalog Number | 5M0564 |
| Lot Number | 93 F 06 |
| ID Number | NA |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 8729 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-07-29 |