MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-05 for BD VACUTAINER? STRETCH LATEX FREE TOURNIQUET 367204 manufactured by Becton Dickinson.
[93806696]
Date of event: unknown. The date received by manufacturer has been used for this field. Results: a sample was not returned for evaluation. The retained boxes were visually inspected for appearance conformity and nothing irregular was seen. A review of the device history record revealed no irregularities during the manufacture of the reported lot #5a004 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
[93806697]
It was reported that bd vacutainer? Stretch latex free tourniquet caused an allergic reaction in a person with auto-immune disease. There was no medical intervention or serious injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2017-00299 |
| MDR Report Key | 7085317 |
| Date Received | 2017-12-05 |
| Date of Report | 2018-01-29 |
| Date of Event | 2015-10-23 |
| Date Mfgr Received | 2015-10-23 |
| 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 | 0 |
| Brand Name | BD VACUTAINER? STRETCH LATEX FREE TOURNIQUET |
| Generic Name | TOURNIQUET |
| Product Code | GAX |
| Date Received | 2017-12-05 |
| Catalog Number | 367204 |
| Lot Number | 5A004 |
| 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 |