MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-06-02 for SAF-T-SHUNT ST-714 N/A manufactured by Akcess.
[399]
Patient had scribner shunt. Lab tech found patient unresponsive in bed with blood in bed and on floor. Code 99 called but unsuccessful. User facility suspects patient tampered with "t" connector. The device had been temporarily removed from service pending its evaluationdevice labeled for single use. Patient medical status prior to event: fair 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: device temporarily removed from service. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 701 |
| MDR Report Key | 701 |
| Date Received | 1992-06-02 |
| Date of Report | 1992-05-14 |
| Date of Event | 1992-05-04 |
| Date Facility Aware | 1992-05-05 |
| Report Date | 1992-05-14 |
| Date Reported to FDA | 1992-05-14 |
| Date Added to Maude | 1992-06-16 |
| 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 | SAF-T-SHUNT |
| Generic Name | SCRIBNER SHUNT |
| Product Code | FIQ |
| Date Received | 1992-06-02 |
| Model Number | ST-714 |
| Catalog Number | N/A |
| Lot Number | AN107 |
| ID Number | NI |
| Operator | OTHER |
| Device Availability | N |
| Device Age | 01-AUG-91 |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 688 |
| Manufacturer | AKCESS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1992-06-02 |