MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-07-23 for QUINTON PERMCATH INSERTION KIT 17749-001 manufactured by Quinton Instrument Co.
[18138315]
(in subsequent follow-up with the rptr it was clarified that the sheath segment was approx 2 x. 3 cm and was manipulated into the right femoral vein by means of a snare. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014398-1997-00074 |
| MDR Report Key | 108011 |
| Report Source | 05,06 |
| Date Received | 1997-07-23 |
| Date of Event | 1997-06-10 |
| Date Mfgr Received | 1997-06-23 |
| Device Manufacturer Date | 1997-03-01 |
| Date Added to Maude | 1997-07-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUINTON PERMCATH INSERTION KIT |
| Generic Name | HEMODIALYSIS CATHETER |
| Product Code | LFK |
| Date Received | 1997-07-23 |
| Model Number | NA |
| Catalog Number | 17749-001 |
| Lot Number | 800789-1997-03 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 2 DAY |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 97811 |
| Manufacturer | QUINTON INSTRUMENT CO |
| Manufacturer Address | 3303 MONTE VILLA PKWY BOTHELL WA 98012 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-07-23 |