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

Catalog Number	367203
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7a004, medical device expiration date: unknown, device manufacture date: 02/02/2007.Bd received samples and photos from the customer facility for investigation.The samples and photos were evaluated and the customer¿s indicated failure mode with the incident lot was observed.Additionally, a review of the manufacturing records was completed for the incident lot and no issues were identified.The supplier has initiated a capa to document further investigation and root cause(s) of this product issue.
Event or Problem Description
It was reported that bd vacutainer® stretch latex free tourniquet had missing and unreadable label information.No serious injury or medical intervention reported.
Additional Manufacturer Narrative
Medical device type is corrected to (b)(4).

• Brand Name: BD VACUTAINER® STRETCH LATEX FREE TOURNIQUET
• Common Device Name: NONPNEUMATIC TOURNIQUET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7611427
• Report Number: 2243072-2018-01197
• Device Sequence Number: 1133926
• Product Code: GAX
• UDI-Device Identifier: 50382903672030
• UDI-Public: 50382903672030
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/20/2018

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?: Yes
• Operator of Device: Other
• Device Catalogue Number: 367203
• Device Lot Number: 7B004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 06/21/2018
• 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