MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® C&S TRANSFER STRAW KIT; CULTURE MEDIA, NON-PROPAGATING TRANSPORT

Catalog Number	364953
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 prior to use of bd vacutainer® c&s transfer straw kit, an unspecified number of kits had the needle inside the straw separated from the straw, including: straws detaching exposing needles, extra straws with needles exposed in the package, and no straw at all in package but holder and tube.Additionally, there were reports of tubes not filling, bent/crimped straws, empty packages, broken plastic and powder inside package, and a double label.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd received 11 photos for investigation, which show the separation of the straw/needle from the holder but do not reveal the customer's indicated failures of no fill/no vacuum, damage, incorrect count, incorrect/missing label info, and fm.Additionally, 10 retained samples were visually inspected, and all components, including the stopper and straw/needle assembly, were found to be correctly assembled with no damage or fm observed, and the labels were correctly placed.Only 10 retained samples are kept for this product; therefore, the incorrect count could not be further investigated.Furthermore, a functional test for draw volume was conducted on 5 retained samples, and all tubes met the specification limits with no issues identified.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: separates.This complaint has not been confirmed for the indicated failure modes: damaged, draw volume(no fill), foreign matter, incorrect count, and label issues.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 use of bd vacutainer® c&s transfer straw kit, an unspecified number of kits had the needle inside the straw separated from the straw, including: straws detaching exposing needles, extra straws with needles exposed in the package, and no straw at all in package but holder and tube.Additionally, there were reports of tubes not filling, bent/crimped straws, empty packages, broken plastic and powder inside package, and a double label.There was no health impact or consequences reported.

• Brand Name: BD VACUTAINER® C&S TRANSFER STRAW KIT
• Common Device Name: CULTURE MEDIA, NON-PROPAGATING TRANSPORT
• 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: 22292973
• Report Number: 1917413-2025-00806
• Device Sequence Number: 12878414
• Product Code: JSM
• UDI-Device Identifier: 30382903649533
• UDI-Public: (01)30382903649533(11)240403(17)251031(10)4094211
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K024240
• 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): 07/30/2025

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 364953
• Device Lot Number: 4094211
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 08/29/2025
• 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