MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-18 for AVC X-TOURN * TRN1184 manufactured by Avcor Healthcare Products, Inc..
[15012890]
When using new tourniquet on patient for a blood draw, while pulling it, the tourniquet broke, allowing the tech to accidentally strike the patient in the face. Patient experienced pain. No permanent injury/harm to patient or staff. What was the original intended procedure? Blood draw. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3178966 |
| MDR Report Key | 3178966 |
| Date Received | 2013-06-18 |
| Report Date | 2013-05-21 |
| Date Reported to FDA | 2013-06-18 |
| Date Reported to Mfgr | 2013-06-20 |
| Date Added to Maude | 2013-06-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVC X-TOURN |
| Generic Name | TOURNIQUET, NONPNEUMATIC |
| Product Code | GAX |
| Date Received | 2013-06-18 |
| Model Number | * |
| Catalog Number | TRN1184 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVCOR HEALTHCARE PRODUCTS, INC. |
| Manufacturer Address | 2320 MICHIGAN CT ARLINGTON TX 76016 US 76016 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-18 | |
| 2 | 0 | 2013-06-18 | |
| 3 | 0 | 2013-06-18 |