MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINE COMPLETE CUP KIT; SYSTEM, TRANSPORT, AEROBIC

Catalog Number	364957
Medical Device Problem Codes	Short Fill (1575); Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E4.The initial reporter also notified the fda in may 2024 according to medwatch report # (b)(4), day of report was not provided.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd vacutainer® urine complete cup kit an unspecified number of tubes had significant condensation and did not fill completely.There was no health impact or consequences reported.
Event or Problem Description
It was reported while using bd vacutainer® urine complete cup kit an unspecified number of tubes had significant condensation and did not fill completely.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos for investigation.Therefore, retention samples from bd inventory were evaluated: 10 retentions were visually inspected with the closure correctly assembled and placed on the tubes with a normal appearance for the additive on the side wall of the tube.Additionally, 5 retains were functionally evaluated for draw volume and all tubes tested within specification requirements.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 is unable to be confirmed for the indicated failure mode underfill and additive abnormality.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 COMPLETE CUP KIT
• Common Device Name: SYSTEM, TRANSPORT, AEROBIC
• 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: 19670238
• Report Number: 1917413-2024-00611
• Device Sequence Number: 15194866
• Product Code: JTW
• UDI-Device Identifier: 00382903649570
• UDI-Public: (01)00382903649570
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 07/30/2024

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: 05/31/2025
• Device Catalogue Number: 364957
• Device Lot Number: 3306885
• 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: 06/07/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2023
• 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