MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-09-15 for URETERAL CATHETERS 334108 manufactured by Rusch, Inc..
[16767945]
It was reported that the catheter seemed blocked and would not allow the flow of an injected die. Two separate adapters with the same lot number appeared to be cracked. Fluid leaked from alleged cracks in adapters. Patients were not in danger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429473-1998-00056 |
| MDR Report Key | 187488 |
| Report Source | 05,06 |
| Date Received | 1998-09-15 |
| Date of Report | 1998-09-14 |
| Date of Event | 1998-08-24 |
| Date Added to Maude | 1998-09-17 |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URETERAL CATHETERS |
| Generic Name | CONE TIP URETERAL CATHETER |
| Product Code | FGF |
| Date Received | 1998-09-15 |
| Model Number | NA |
| Catalog Number | 334108 |
| Lot Number | 83319, 817001 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 182238 |
| Manufacturer | RUSCH, INC. |
| Manufacturer Address | 2450 MEADOWBROOK PARKWAY DULUTH GA 30136 US |
| Baseline Brand Name | CONE TIP URETERAL 8FR |
| Baseline Generic Name | URETERAL CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 334108 |
| Baseline ID | NA |
| Baseline Device Family | URETERAL CATHETERS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-09-15 |