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

Model Number 364953

Device Problems Fluid/Blood Leak (1250); Misassembly During Maintenance/Repair (4054)

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

Event Date 08/20/2021

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 when using the bd vacutainer® c&s transfer straw kit the needle inside the transfer straw was dislodged and loose from the straw." this event occurred 2 times.The following information was provided by the initial reporter.The customer stated: the customer "pushed the tube into the adapter and the needle pushed into the straw.Rubber stopper on vial is not punctured.In the drawer was another unopened package with the needle/straw/adapter connection issue.It is as if they forgot to apply the adhesive.".

• 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: 12482031
• MDR Text Key: 271914543
• Report Number: 1917413-2021-00813
• 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
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 08/20/2021
• 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