MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINALYSIS TRANSFER STRAW KIT; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number 364991

Device Problem Component Missing (2306)

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

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 bd vacutainer® urinalysis transfer straw kit was missing the additive.The following information was provided by the initial reporter: it was reported that the tubes have no additive inside the tubes.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 1917413-2021-01058 was sent in error.This product is a non additive tube, therefore, this is not considered to be a reportable malfunction.

Event Description

It was reported that the bd vacutainer® urinalysis transfer straw kit was missing the additive.The following information was provided by the initial reporter: it was reported that the tubes have no additive inside the tubes.

• Brand Name: BD VACUTAINER® URINALYSIS TRANSFER STRAW KIT
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13003170
• MDR Text Key: 285013341
• Report Number: 1917413-2021-01058
• Device Sequence Number: 1
• Product Code: KDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 364991
• Device Lot Number: 1190380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• 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