MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-11-12 for QUINTON CATHETER * UNK manufactured by Kendall.
[162267]
Cannulation of the right femoral vein was successful in a pt. Who needed emergent dialysis. The physician also successfully threaded the wire into the vessel and had placed the catheter over the wire. When trying to remove the wire, he experienced some resistance. As he was pulling back on the free end of the wire, the outer "sheath" cut through 2 sets of gloves and pierced his skin and drew blood. The entire unit was removed after washing his hands and donning new gloves.
Patient Sequence No: 1, Text Type: D, B5
[16819850]
Cannulation of the right femoral vein was successful in a pt. Who needed emergent dialysis. The physician also successfully threaded the wire into the vessel and had placed the catheter over the wire. When trying to remove the wire, he experienced some resistance. As he was pulling back on the free end of the wire, the outer "sheath" cut through 2 sets of gloves and pierced his skin and drew blood. The entire unit was removed after washing his hands and donning new gloves.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032312-1999-01015 |
| MDR Report Key | 250019 |
| Report Source | 07 |
| Date Received | 1999-11-12 |
| Date of Report | 1999-11-11 |
| Date Mfgr Received | 1999-10-13 |
| Date Added to Maude | 1999-11-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | CYNTHIA PROVENCHER |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618155 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUINTON CATHETER |
| Generic Name | DIALYSIS CATHETER |
| Product Code | LFK |
| Date Received | 1999-11-12 |
| Model Number | * |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 242224 |
| Manufacturer | KENDALL |
| Manufacturer Address | 15 HAMPSHIRE ST MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-11-12 |