MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-06-16 for FIVE PRONG CYCLER SET N/A 020-11005 manufactured by Fresenius, Inc..
[610]
Capd patient used delclamp at home. Clamp perforated tubing and allowed leakage of fluid. Patient placed at risk for peritonitis and given i. V. Antibodiecs. No signs or symptoms of peritonitis at time of reportinginvalid data - regarding single use labeling of device. 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: actual device involved in incident was evaluated, visual examination. Results of evaluation: component failure. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 728 |
| MDR Report Key | 728 |
| Date Received | 1992-06-16 |
| Date of Report | 1992-06-01 |
| Date of Event | 1992-05-21 |
| Date Facility Aware | 1992-05-22 |
| Report Date | 1992-06-01 |
| Date Reported to FDA | 1992-06-01 |
| Date Reported to Mfgr | 1992-05-22 |
| Date Added to Maude | 1992-06-17 |
| 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 | FIVE PRONG CYCLER SET |
| Generic Name | DEL CLAMP |
| Product Code | FFR |
| Date Received | 1992-06-16 |
| Model Number | N/A |
| Catalog Number | 020-11005 |
| Lot Number | 1M-001-07X |
| ID Number | N/A |
| Operator | OTHER |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 713 |
| Manufacturer | FRESENIUS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-06-16 |