MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-19 for DISPOSABLE BIOPSY PACK 398956C-E manufactured by Argon Medical Corp..
[19901448]
Suspected contamination: on 3/21/94 while setting up to do a routine right ventricular endocardial biopsy on a heart transplant pt, using a disposable biopsy pack, and after pouring sterile iv ns solution into the plastic bowls, a nurse noticed a "film of oil" floating on the liquid in the bowls. The liquid was found to have a "film" on top plus what appeared to be globules suspended near the surface. A sample of the liquid was placed in a sterile container and the bowl retained. A new metallic bowl was added to the tray in which sterile iv ns solution was poured. The liquid was clear and free of any "film. " on thursday, 3/24/94, two different trays showed a "film" on the sterile iv ns in the bowls. Metallic bowls were once again substituted and the liquid in them was clear and free of "film. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001647 |
| MDR Report Key | 12814 |
| Date Received | 1994-04-19 |
| Date of Report | 1994-04-07 |
| Date of Event | 1994-03-21 |
| Date Added to Maude | 1994-04-20 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE BIOPSY PACK |
| Product Code | DWZ |
| Date Received | 1994-04-19 |
| Catalog Number | 398956C-E |
| Lot Number | 93087260, 93087261 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 12813 |
| Manufacturer | ARGON MEDICAL CORP. |
| Manufacturer Address | ATHENS TX 75751 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-04-19 |