MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2003-09-15 for REUSABLE CATHETER PASSER * SP02 manufactured by Phoenix Biomedical.
[331126]
The reusable catheter passer is a non-sterile stainless steel instrument. The instruction for use identifies the product as non-sterile and indicates the steam sterilization procedures. The product label also states that the product is non-sterile. However, the label used, can be used for eo sterilization. It states "sterile, eo", "sterile unless inner package is open or damaged" and "indicator dot turns brown when sterile", although the eo indicator dot on the label is blue indicating that it has not been exposed to eo gas. Because of the conflicting statements on the label, sterility of the product is not clear. As a result, non-sterile product was used on a pt. This event was discovered the same day and the pt is being treated with antibiotics, and infection has not occurred to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518608-2003-00003 |
| MDR Report Key | 485425 |
| Report Source | 04,05,06 |
| Date Received | 2003-09-15 |
| Date of Report | 2003-09-09 |
| Date of Event | 2003-09-05 |
| Device Manufacturer Date | 2002-09-01 |
| Date Added to Maude | 2003-09-30 |
| 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 |
| Manufacturer Contact | COURTNEY SMITH |
| Manufacturer Street | P.O. BOX 80390 |
| Manufacturer City | VALLEY FORGE PA 19484 |
| Manufacturer Country | US |
| Manufacturer Postal | 19484 |
| Manufacturer Phone | 6105399300 |
| Manufacturer G1 | * |
| Manufacturer Street | 2495 GENERAL ARMISTEAD AVE |
| Manufacturer City | NORRISTOWN PA 19403 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19403 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REUSABLE CATHETER PASSER |
| Generic Name | CATHETER PASSER |
| Product Code | GBS |
| Date Received | 2003-09-15 |
| Model Number | * |
| Catalog Number | SP02 |
| Lot Number | K0701 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 474311 |
| Manufacturer | PHOENIX BIOMEDICAL |
| Manufacturer Address | P.O. BOX 80390 VALLEY FORGE PA 19484 US |
| Baseline Brand Name | REUSABLE CATHETER PASSER |
| Baseline Generic Name | CATHETER PASSER |
| Baseline Model No | * |
| Baseline Catalog No | SP02 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-09-15 |