MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,07 report with the FDA on 2011-02-16 for BD VACUTAINER STRETCH LATEX FREE TOURNIQUET 367203 manufactured by Hygenic Corp..
[1929298]
The customer reported that a tourniquet was being used by a phlebotomist who experienced throat irritation from the smell of the tourniquet and skin irritation with the use. The phlebotomist went to the employee health department and then to the emergency department. The ed physician confirmed there was a "reaction to something". No add'l info was made available due to privacy considerations.
Patient Sequence No: 1, Text Type: D, B5
[8834687]
The bd vacutainer stretch latex free tourniquet is made specifically for practitioners and the facilities that choose to eliminate latex from their health care products. This product is made with synthetic polyisoprene which will not cause a latex-induced allergic reaction in latex-sensitive patients or employees. This device has a vanilla scent that masks the natural odor of the product, which from marketing testing, was not pleasing. A complaint history review was performed for the identified lot and this is the first recorded complaint. The customer returned product from the lot they reported but not the actual tourniquet which was involved in the reported incident. No issues were found with the returned product. All batch records associated with the lot were reviewed and the raw materials as well as the processing parameters were within specifications. It was also confirmed that there were no changes made to the raw materials, suppliers of raw materials or formulation of the product. The cytotoxicity, skin sensitization and skin irritation studies which were performed did not reveal any evidence that there is a potential for the product to cause any allergic reaction as was reported. Regulatory compliance will continue to track and trend this condition on a monthly basis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519375-2011-00001 |
| MDR Report Key | 2003188 |
| Report Source | 04,05,07 |
| Date Received | 2011-02-16 |
| Date of Report | 2011-02-16 |
| Date of Event | 2011-01-14 |
| Date Mfgr Received | 2010-01-19 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2012-05-17 |
| 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 | RICH VALES |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal | 07417 |
| Manufacturer Phone | 2018475636 |
| Manufacturer G1 | HYGENIC CORP. |
| Manufacturer Street | 1245 HOME AVE. |
| Manufacturer City | AKRON OH 44310 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44310 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD VACUTAINER STRETCH LATEX FREE TOURNIQUET |
| Generic Name | TOURNIQUET |
| Product Code | GAX |
| Date Received | 2011-02-16 |
| Model Number | NA |
| Catalog Number | 367203 |
| Lot Number | OK002 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HYGENIC CORP. |
| Manufacturer Address | 1245 HOME AVE. AKRON OH 44310 US 44310 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-02-16 |