MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-12 for DUAL LUMEN CATHETER KIT 17748-001 manufactured by Quinton Instrument Co..
[10525]
Male patient in 50's admitted for bone marrow transplant. Catheter inserted by physician in subclavin artery. An iv was hooked up to the catheter, dressing became soaked. Chest x-ray showed catheter was severed. Patient went to surgery to remove catheter. A part of the clavicle was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1483039-1994-00006 |
| MDR Report Key | 13474 |
| Date Received | 1994-04-12 |
| Date of Report | 1994-03-28 |
| Date of Event | 1994-03-16 |
| Date Facility Aware | 1994-03-24 |
| Report Date | 1994-03-28 |
| Date Reported to FDA | 1994-03-28 |
| Date Reported to Mfgr | 1994-03-24 |
| Date Added to Maude | 1994-05-25 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUAL LUMEN CATHETER KIT |
| Generic Name | CATHETER KIT |
| Product Code | GBP |
| Date Received | 1994-04-12 |
| Returned To Mfg | 1994-03-26 |
| Model Number | NA |
| Catalog Number | 17748-001 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 13472 |
| Manufacturer | QUINTON INSTRUMENT CO. |
| Manufacturer Address | 2121 TERRY AVENUE SEATTLE WA 981212701 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-04-12 |