MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® STRETCH LATEX FREE TOURNIQUET

Catalog Number	367203
Health Effect - Clinical Codes	Headache (1880); Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076); Reaction (2414)
Date of Event	05/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
The initial mdr was submitted with an incorrect 510k number.It is corrected to read exempt.

• Brand Name: BD VACUTAINER® STRETCH LATEX FREE TOURNIQUET
• Common Device Name: TOURNIQUET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7082710
• Report Number: 2243072-2017-00298
• Device Sequence Number: 1130619
• Product Code: GAX
• UDI-Device Identifier: 00382903672035
• UDI-Public: 00382903672035
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Catalogue Number: 367203
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2016
• Supplement Date Received by Manufacturer: 05/05/2016
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other