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	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported prior to using bd vacutainer® urine transfer straw, needles were seen poking through the sides of hubs and there were loose needles in the bag.It is unspecified how many defective needles there were.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
D.4.Medical device expiration date: not applicable, this material does not have an expiration date a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields have been updated with additional information: d10.Device available for eval- yes.D10.Returned to manufacturer on: 03-jan-2024.H3.Device eval by manufacturer- yes.Investigation summary - bd received 15 samples and seven (7) photos for investigation.A visual examination of the returned samples and photos revealed improper assembly, causing the transfer straw to not be placed correctly on the holder.Retention samples were not evaluated for this complaint as no retentions are kept for this product.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.This complaint has been confirmed for the indicated failure mode incorrect placement of component on product based on customer provided photos and returns.No definitive root cause could be established for the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for the identification of emerging trends.
Event or Problem Description
It was reported prior to using bd vacutainer® urine transfer straw, needles were seen poking through the sides of hubs and there were loose needles in the bag.It is unspecified how many defective needles there were.No adverse impact was reported regarding the patient or user.

• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21464864
• Report Number: 1917413-2025-00178
• Device Sequence Number: 15663641
• Product Code: JTW
• UDI-Device Identifier: 50382903649667
• UDI-Public: (01)50382903649667(11)240805(10)4218948
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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: 4218948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2024
• 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