MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-18 for BD VACUTAINER? STRETCH LATEX FREE TOURNIQUET 367203 manufactured by Becton Dickinson.
[111852391]
(b)(4). There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 7a004, medical device expiration date: unknown, device manufacture date: 02/02/2007. Bd received samples and photos from the customer facility for investigation. The samples and photos were evaluated and the customer? S indicated failure mode with the incident lot was observed. Additionally, a review of the manufacturing records was completed for the incident lot and no issues were identified. The supplier has initiated a capa to document further investigation and root cause(s) of this product issue.
Patient Sequence No: 1, Text Type: N, H10
[111852393]
It was reported that bd vacutainer? Stretch latex free tourniquet had missing and unreadable label information. No serious injury or medical intervention reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-01197 |
| MDR Report Key | 7611427 |
| Date Received | 2018-06-18 |
| Date of Report | 2018-06-20 |
| Date of Event | 2017-09-13 |
| Date Mfgr Received | 2017-09-13 |
| Device Manufacturer Date | 2007-03-16 |
| Date Added to Maude | 2018-06-18 |
| 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 VACUTAINER? STRETCH LATEX FREE TOURNIQUET |
| Generic Name | NONPNEUMATIC TOURNIQUET |
| Product Code | GAX |
| Date Received | 2018-06-18 |
| Returned To Mfg | 2017-10-06 |
| Catalog Number | 367203 |
| Lot Number | 7B004 |
| 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 | 2018-06-18 |