MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-14 for BD VACUTAINER? C&S BORIC ACID KIT SODIUM BORATE/FORMATE 364944 manufactured by Becton, Dickinson & Co..
[117268011]
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 7333954, medical device expiration date: 2019-06-30, device manufacture date: 2017-11-29. Medical device lot #: 7333955, medical device expiration date: 2019-06-30, device manufacture date: 2017-11-29. (b)(6). 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
[117268012]
It was reported with the use of the bd vacutainer? C&s boric acid kit sodium borate/formate there was an issue with closure separation. There was no report of injury or further medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2018-03295 |
| MDR Report Key | 7783096 |
| Date Received | 2018-08-14 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-07-30 |
| Date Mfgr Received | 2018-07-30 |
| Date Added to Maude | 2018-08-14 |
| 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 & CO. |
| Manufacturer Street | 150 SOUTH 1ST AVENUE |
| Manufacturer City | BROKEN BOW NE 68822 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68822 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD VACUTAINER? C&S BORIC ACID KIT SODIUM BORATE/FORMATE |
| Generic Name | TRANSPORT CULTURE MEDIUM |
| Product Code | LIO |
| Date Received | 2018-08-14 |
| Catalog Number | 364944 |
| Lot Number | SEE H.10 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-14 |