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

Catalog Number 364953

Device Problem Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® c&s transfer straw kit it pierced the tube stopper and got stuck on the stopper of the tube.The following information was provided by the initial reporter.The customer stated: customer problem: customer reports a malfunction with a straw from urine collection kit 364953, lot#:2187420.Straw malfunction, it pierced the tube stopper and got stuck on the stopper of the tube.

Event Description

It was reported when using the bd vacutainer® c&s transfer straw kit it pierced the tube stopper and got stuck on the stopper of the tube.The following information was provided by the initial reporter.The customer stated: customer problem: customer reports a malfunction with a straw from urine collection kit 364953, lot#:2187420.Straw malfunction, it pierced the tube stopper and got stuck on the stopper of the tube.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to straw malfunction as all samples met specifications.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 straw malfunction.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.H3 other text : see h.10.

• Brand Name: BD VACUTAINER® C&S TRANSFER STRAW KIT
• Type of Device: TRANSPORT CULTURE MEDIUM
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17722648
• MDR Text Key: 323115066
• Report Number: 1917413-2023-00894
• Device Sequence Number: 1
• Product Code: JSM
• UDI-Device Identifier: 50382903649537
• UDI-Public: 50382903649537
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 364953
• Device Lot Number: 2187420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1