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

Model Number 364953

Device Problem Break (1069)

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

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

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 that the transfer straw was broken with a bd vacutainer® c&s transfer straw kit.The following information was provided by the initial reporter: it was reported that the transfer straw was broken.

Manufacturer Narrative

H6: investigation summary bd had not received samples, but one (1) photo was provided for investigation.The photo was reviewed and revealed the presence of improper assembly/placement of product causing an extra straw and needle assembly to be in the bag without a holder.Per the specification, one transfer unit, including the straw, needle, and holder, is to be in the bag with the collection vacutainer.Additionally, (b)(4) retention samples from bd inventory were evaluated by visual examination and the issues of improper assembly/placement and difficult to open packaging were not observed.There were no extra transfer units identified and all needles had the holder attached properly.No issues were seen with the packaging that would cause it to be difficult to be opened.All preformation marks were visible.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 notifications.This complaint has been confirmed for the indicated failure mode of improper assembly/placement of product with the photo provided; however, unconfirmed for the indicated failure mode of difficult to open packaging with the photo provided.

Event Description

It was reported that the transfer straw was broken with a bd vacutainer® c&s transfer straw kit.The following information was provided by the initial reporter: it was reported that the transfer straw was broken.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12858153
• MDR Text Key: 285003246
• Report Number: 1917413-2021-01005
• 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: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 364953
• Device Catalogue Number: 364953
• Device Lot Number: 1127686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• 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