MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINALYSIS TRANSFER STRAW KIT; EVACUATED URINE SPECIMEN CONTAINER IVD, PRESERVATIVE

Catalog Number	364943
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: bd received 1 photo for investigation.The photo was reviewed and the indicated failure mode for separation was observed.Regular inspections for the adhesive bond where the bond will not be broken with a force of 5 lbs.The uv sensor is challenged to make sure the glue is cured.Additionally, the photo depicts an extra straw/needle assembly is present in one bag and is missing in the other bag.Therefore incorrect count can be seen in the photo.Ten (10) retention samples from bd inventory were evaluated by visual examination and the issues of separation and incorrect count were 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 issues during manufacturing of the product.This complaint has been confirmed for the indicated failure modes separation and incorrect count.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.
Event or Problem Description
It was reported before using the bd vacutainer® urinalysis transfer straw kit one straw separated from the holder.Additionally one kit had a half a straw missing while another kit had half a straw extra.There were no health consequences or impacts reported.

• Brand Name: BD VACUTAINER® URINALYSIS TRANSFER STRAW KIT
• Common Device Name: EVACUATED URINE SPECIMEN CONTAINER IVD, PRESERVATIVE
• 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: 20434306
• Report Number: 1917413-2024-00964
• Device Sequence Number: 12664493
• Product Code: JTW
• UDI-Device Identifier: 30382903649434
• UDI-Public: (01)30382903649434(11)240403(17)251031(10)4094201
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 09/30/2024

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 364943
• Device Lot Number: 4094201
• 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: 09/20/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2024
• 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