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.
[64525447]
Opened a sterile venous pack for a procedure and noted a couple of black specks in the sterile bowl. When adding saline to bowl, the black specks floated. Discarded tray and retrieved new one for procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067149 |
| MDR Report Key | 6237721 |
| Date Received | 2017-01-09 |
| Date of Report | 2017-01-09 |
| Date of Event | 2016-12-21 |
| 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 | 2017-01-04 |
| 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 |