MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-31 for SWAN NECK MISSOURI PERTIONEAL DIALYSIS CATHETER - LEFT UNKNOWN SNM 2 - LEFT manufactured by Accurate Surgical Instrument Company.
[2270]
Patient had capd cath placed 5/19/92. Returned to health to health center 5/31/92 with possible infected catheter. Was taken to or for removal of catheter. Antibiotics given. Discharge diagnosis stated malfunctioning vascular capd catheter. Device 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: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: maybe. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3476 |
| MDR Report Key | 3476 |
| Date Received | 1992-07-31 |
| Date of Report | 1992-07-28 |
| Date of Event | 1992-05-31 |
| Date Facility Aware | 1992-07-08 |
| Report Date | 1992-07-28 |
| Date Reported to FDA | 1992-07-28 |
| Date Reported to Mfgr | 1992-07-28 |
| Date Added to Maude | 1993-04-20 |
| 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 | SWAN NECK MISSOURI PERTIONEAL DIALYSIS CATHETER - LEFT |
| Generic Name | CAPD CATHETER |
| Product Code | FKO |
| Date Received | 1992-07-31 |
| Model Number | UNKNOWN |
| Catalog Number | SNM 2 - LEFT |
| Lot Number | HX70 - 12 - 30 |
| ID Number | UNKNOWN |
| Device Availability | Y |
| Device Age | 01-MAY-92 |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 3218 |
| Manufacturer | ACCURATE SURGICAL INSTRUMENT COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-31 |