MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINE TRANSFER STRAW; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number	364966
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Medical device expiration date: this product does not have an expiration date.H3.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 while using the bd vacutainer® urine transfer straw that the collection needle and straw component were separating from the cup.There was no health impact or consequence reported.
Event or Problem Description
It was reported while using the bd vacutainer® urine transfer straw that the collection needle and straw component were separating from the cup.There was no health impact or consequence reported.
Additional Manufacturer Narrative
H.6 investigation summary: bd had not received samples, but three (3) photos were provided for investigation.The photos were reviewed and the indicated failure mode for separation of the holder, straw, and needle assembly was 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 issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode of separation.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VACUTAINER® URINE TRANSFER STRAW
• Common Device Name: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19287075
• Report Number: 1917413-2024-00401
• Device Sequence Number: 12842216
• Product Code: JTW
• UDI-Device Identifier: 50382903649667
• UDI-Public: (01)50382903649667
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K790366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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: 364966
• Device Lot Number: 3278071
• 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: 04/12/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2023
• 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