MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-12-20 for CATHETER ADAPTER SEALING CAP 48-1002-8 manufactured by Fresenius Usa, Inc..
[15980]
Home pt reported that sealing cap leaked immediately after application. Pt has no eviodence of infection. There was no medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1993-00256 |
| MDR Report Key | 23867 |
| Date Received | 1993-12-20 |
| Date of Report | 1993-12-15 |
| Date of Event | 1993-12-13 |
| Date Facility Aware | 1993-12-13 |
| Report Date | 1993-12-15 |
| Date Reported to Mfgr | 1993-12-15 |
| Date Added to Maude | 1995-07-31 |
| 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 | CATHETER ADAPTER SEALING CAP |
| Generic Name | SEALING CAP |
| Product Code | KQQ |
| Date Received | 1993-12-20 |
| Model Number | NA |
| Catalog Number | 48-1002-8 |
| Lot Number | 8600607 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 24202 |
| Manufacturer | FRESENIUS USA, INC. |
| Manufacturer Address | 475 W. 13TH STREET OGDEN UT 84404 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1993-12-20 |