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 2017-12-05 for BD VACUTAINER? STRETCH LATEX FREE TOURNIQUET 367203 manufactured by Becton Dickinson.
[93724323]
Medical device expiration date: unknown. Device manufacture date: unknown. Results: a sample was not returned for evaluation. A review of the device history record could not be performed as a lot number was not provided for this incident. Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer? S indicated failure mode.
Patient Sequence No: 1, Text Type: N, H10
[93724324]
It was reported that bd vacutainer? Stretch latex free tourniquet caused allergic reactions in two people. One reported congestion, headache, cough and respiratory issues. The other had dermatitis and hives. Both were reassigned to work in another area. No medical intervention reported for the reactions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2017-00298 |
| MDR Report Key | 7082710 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2017-12-05 |
| Date of Report | 2018-01-29 |
| Date of Event | 2016-05-05 |
| Date Mfgr Received | 2016-05-05 |
| Date Added to Maude | 2017-12-05 |
| 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 LATEX FREE TOURNIQUET |
| Generic Name | TOURNIQUET |
| Product Code | GAX |
| Date Received | 2017-12-05 |
| Catalog Number | 367203 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| 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 | 2017-12-05 |