MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2018-03-05 for BD VACUTAINER??STRETCH TOURNIQUET 367199 manufactured by Becton Dickinson.
[101561943]
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
[101561944]
It was reported that the bd vacutainer? Stretch tourniquets are stiffer, have an oily feel and in one case the technician had an allergic reaction. No reports of medical intervention noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-00094 |
| MDR Report Key | 7314553 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2018-03-05 |
| Date of Report | 2018-06-22 |
| Date of Event | 2018-02-09 |
| Date Mfgr Received | 2018-02-09 |
| Device Manufacturer Date | 2017-06-15 |
| Date Added to Maude | 2018-03-05 |
| 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 | 3 |
| Brand Name | BD VACUTAINER??STRETCH TOURNIQUET |
| Generic Name | TOURNIQUET |
| Product Code | GAX |
| Date Received | 2018-03-05 |
| Returned To Mfg | 2018-02-28 |
| Catalog Number | 367199 |
| Lot Number | 7121014 |
| 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 | 2018-03-05 |