MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-10 for BD VECAFIX? IV DRESSING WITHOUT TRANSPARENT WINDOW 392015 manufactured by Becton Dickinson.
[119934713]
The manufacturing location for this product is attends. This site is an oem manufacturing site. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[119934714]
It was reported that a bd vecafix? Iv dressing without transparent window had a breach in the sterile packaging due to adhesive delamination. No serious injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-01305 |
| MDR Report Key | 7860787 |
| Date Received | 2018-09-10 |
| Date of Report | 2018-10-09 |
| Date of Event | 2018-08-20 |
| Date Mfgr Received | 2018-08-20 |
| Device Manufacturer Date | 2015-08-15 |
| Date Added to Maude | 2018-09-10 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652845 |
| Manufacturer G1 | BECTON DICKINSON |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD VECAFIX? IV DRESSING WITHOUT TRANSPARENT WINDOW |
| Generic Name | IV DRESSING |
| Product Code | KMK |
| Date Received | 2018-09-10 |
| Catalog Number | 392015 |
| Lot Number | 121662 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-10 |