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

Catalog Number	367203
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd tourniquet stretch latex free, the device experienced no label or missing label information.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: 5 units of the product have been delivered to customer without batch # and no exp.Date either.
Additional Manufacturer Narrative
In this mdr, bd corporate headquarters in (b)(4) has been listed.As hygenic is an oem manufacturing site.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
In this mdr, bd corporate headquarters in (b)(4) has been listed.As hygenic is an oem manufacturing site.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd tourniquet stretch latex free, the device experienced no label or missing label information.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: 5 units of the product have been delivered to customer without batch # and no exp.Date either.
Additional Manufacturer Narrative
Investigation: bd had not received samples, but 3 photos were provided by the customer for investigation.The photos were reviewed and the indicated failure mode for missing batch, expiration date with the incident lot was observed.Additionally, retention samples from bd inventory were evaluated by visual examination and the issue of missing batch, expiration date was not observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality non-conformance's during manufacturing of the product.This complaint has been confirmed via photos provided by the customer for the indicated failure mode missing batch, expiration date.
Event or Problem Description
It was reported when using the bd tourniquet stretch latex free, the device experienced no label or missing label information.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: 5 units of the product have been delivered to customer without batch # and no exp.Date either.

• Brand Name: BD TOURNIQUET STRETCH LATEX FREE
• Common Device Name: NONPNEUMATIC TOURNIQUET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13260529
• Report Number: 2243072-2021-03128
• Device Sequence Number: 5912775
• Product Code: GAX
• UDI-Device Identifier: 00382903672035
• UDI-Public: 00382903672035
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 367203
• Device Lot Number: 1E002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown