MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-21 for 8" CATHETER EXTENSION 4330288 05030027-W manufactured by Freseniuss Usa, Inc.
[18827740]
Facility alleges crack was noticed in conneector of 8" cath extension, during drainage, by pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1994-08004 |
| MDR Report Key | 13861 |
| Date Received | 1994-03-21 |
| Date of Report | 1994-02-17 |
| Date Facility Aware | 1994-02-11 |
| Report Date | 1994-02-18 |
| Date Reported to Mfgr | 1994-02-18 |
| Date Added to Maude | 1994-06-09 |
| 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 | 8" CATHETER EXTENSION |
| Generic Name | CONNECTOR SITE TUBING |
| Product Code | FKY |
| Date Received | 1994-03-21 |
| Model Number | 4330288 |
| Catalog Number | 05030027-W |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 13859 |
| Manufacturer | FRESENIUSS USA, INC |
| Manufacturer Address | 2637 SHADELANDS DRIVE WALNUT CREEK CA 94598 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-03-21 |