MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-08-13 for MULTI MED M3720HKI * manufactured by Baxter-edwards Div.
[245321]
During insertion of triple lumen catheter, when trying to remove guidewire, it became apparent that the guidewire was frayed and locked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1022630 |
| MDR Report Key | 347203 |
| Date Received | 2001-08-13 |
| Date of Report | 2001-08-13 |
| Date of Event | 2001-08-03 |
| Date Added to Maude | 2001-08-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTI MED |
| Generic Name | TRIPLE LUMEN CATHETER |
| Product Code | GBP |
| Date Received | 2001-08-13 |
| Model Number | M3720HKI |
| Catalog Number | * |
| Lot Number | 940L0313 |
| ID Number | * |
| Device Expiration Date | 2002-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 336510 |
| Manufacturer | BAXTER-EDWARDS DIV |
| Manufacturer Address | 17721 RED HILL AVE IRVINE CA 926145686 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-08-13 |