MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-20 for BD VECAFIX? VECA - C? IV DRESSINGS 392020 manufactured by Becton Dickinson.
[112034167]
"there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 122241, medical device expiration date: 02/29/2020, device manufacture date: 08/13/2015. Medical device lot #: 123426, medical device expiration date: 08/31/2020, device manufacture date: 01/05/2016. (b)(4). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[112034168]
It was reported that 2 packages from lot. 122241 of the bd vecafix? Veca - c? Iv dressings, and 6 packages from lot 123426 were open prior to use. No reports of serious injury or medical intervention noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-00397 |
| MDR Report Key | 7621550 |
| Date Received | 2018-06-20 |
| Date of Report | 2018-07-18 |
| Date of Event | 2018-05-29 |
| Date Mfgr Received | 2018-05-30 |
| Date Added to Maude | 2018-06-20 |
| 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 |
| 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? VECA - C? IV DRESSINGS |
| Generic Name | IV START KIT |
| Product Code | KMK |
| Date Received | 2018-06-20 |
| Returned To Mfg | 2018-06-05 |
| Catalog Number | 392020 |
| Lot Number | SEE H.10 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-06-20 |