MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-09 for DEROYAL VENOUS PACK BOWL 89-8672.02 manufactured by Deroyal.
[64525078]
Opened sterile venous pack lot #43483479 to prep for pt procedure. Noted a small back speck in sterile bowl. No saline or other products were added to the bowl. Black speck is loose and moves in bowl. The entire drape was folded, and closed and entire tray not used. This was noted before any procedure and no products from this tray came in contact with the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067146 |
| MDR Report Key | 6237685 |
| Date Received | 2017-01-09 |
| Date of Report | 2017-01-09 |
| Date of Event | 2017-01-06 |
| Date Added to Maude | 2017-01-10 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DEROYAL VENOUS PACK BOWL |
| Generic Name | VENOUS PACK BOWL 16 OZ |
| Product Code | PEZ |
| Date Received | 2017-01-09 |
| Returned To Mfg | 2017-01-09 |
| Model Number | 89-8672.02 |
| Lot Number | 43483479 |
| Device Expiration Date | 2019-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL |
| Manufacturer Address | POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-09 |