MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-17 for DEROYAL VENOUS PACK SET UP COVER 89-8672.04 manufactured by Deroyal Industries, Inc..
[114460031]
Venous pack lot # 47260555 was opened for a pt procedure. A black foreign body was noted on the drape when preparing the tray. No part of the tray came into contact with pt. The tray was removed and another tray opened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078437 |
| MDR Report Key | 7697652 |
| Date Received | 2018-07-17 |
| Date of Report | 2018-07-13 |
| Date of Event | 2018-07-12 |
| Date Added to Maude | 2018-07-18 |
| 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 SET UP COVER |
| Generic Name | CENTRAL VENOUS CATHETER PRESSING CHANGE KIT |
| Product Code | PEZ |
| Date Received | 2018-07-17 |
| Catalog Number | 89-8672.04 |
| Lot Number | 47260555 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-17 |