MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER URINE COMPLETE CUP KIT; TRANSPORT CULTURE MEDIUM

Model Number 364956

Device Problems Leak/Splash (1354); Short Fill (1575); Volume Accuracy Problem (1675)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that bd vacutainer¿ urine complete cup kit underfilled and leaked.The following information was provided by the initial reporter: "material no: 364956, batch no: 0281691.It was reported that the tube is leaking and is not filling properly.Date: (b)(6) 2020.Time: 10 am.Harm: none.Id: (b)(6).Department: ed.Description: urine would not flow into tube.Try to manually fill with blank tip (i think blunt tip was meant) and noted leaking around rubber stop in tube and small leak in tube itself.Product saved: yes.Manf #: 364956 lot # unknown at this time.Affect product: 1 kit.".

Manufacturer Narrative

H.6.Investigation: bd had not received samples, but one (1) photo was provided by the customer for investigation.The photo was reviewed and the indicated failure mode for leakage and draw volume with the incident lot was not observed.Additionally, five (5) retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to leakage and draw volume 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.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported that bd vacutainer® urine complete cup kit underfilled and leaked.The following information was provided by the initial reporter: "material no: 364956 batch no: 0281691 it was reported that the tube is leaking and is not filling properly.Date: (b)(6) 2020.Time: 10 am.Harm: none.Id:(b)(6).Department: ed description: urine would not flow into tube.Try to manually fill with blank tip (i think blunt tip was meant) and noted leaking around rubber stop in tube and small leak in tube itself.Product saved: yes.Manf #:364956.Lot # unknown at this time affect product: 1 kit".

• Brand Name: BD VACUTAINER URINE COMPLETE CUP KIT
• Type of Device: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 11166774
• MDR Text Key: 229816537
• Report Number: 1917413-2021-00015
• Device Sequence Number: 1
• Product Code: JSM
• UDI-Device Identifier: 50382903649568
• UDI-Public: 50382903649568
• Combination Product (y/n): N
• PMA/PMN Number: K024240
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: 364956
• Device Catalogue Number: 364956
• Device Lot Number: 0281691
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1