MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® URINALYSIS CUP KIT; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number 364989

Device Problems Leak/Splash (1354); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

Bd received photos from the customer facility for investigation.This complaint is confirmed to be within the scope of a known issue.Quality has previously reviewed, evaluated and investigated this failure mode.No further action is required at this time.Based on evaluation of the complaint information, this complaint meets the criteria for a previously investigated complaint; reference (b)(4).

Event Description

It was reported that a bd vacutainer® urinalysis cup kit contained tubes that were collapsed.No report of serious injury or medical intervention.

Manufacturer Narrative

Additional information: the device history records for batch 7038944 have been reviewed with no issues being identified.

Event Description

It was reported that a bd vacutainer® urinalysis cup kit contained tubes that were collapsed.No report of serious injury or medical intervention.

• Brand Name: BD VACUTAINER® URINALYSIS CUP KIT
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7621726
• MDR Text Key: 112028232
• Report Number: 1917413-2018-02908
• Device Sequence Number: 1
• Product Code: KDT
• UDI-Device Identifier: 50382903649896
• UDI-Public: 50382903649896
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 364989
• Device Lot Number: 7038944
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 11/20/2017
• Supplement Dates FDA Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other