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

Model Number 364956

Device Problems Short Fill (1575); Volume Accuracy Problem (1675)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown, device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported the bd vacutainer® urine complete cup kit experienced under-fill or low draw.The following information was provided by the initial reporter.The customer stated there was a "filling issue when using urine tube that is included in urine kit.The customer "could not get urine to suction into tubes.Unsure if it was faulty tubes or lid on cup.Opened another kit and poured urine into a new cup and was able to transfer urine to new tubes.".

Manufacturer Narrative

Investigation summary: bd had not received samples or photos from the customer for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.

Event Description

It was reported the bd vacutainer® urine complete cup kit experienced under-fill or low draw.The following information was provided by the initial reporter.The customer stated there was a "filling issue when using urine tube that is included in urine kit.The customer "could not get urine to suction into tubes.Unsure if it was faulty tubes or lid on cup.Opened another kit and poured urine into a new cup and was able to transfer urine to new tubes.".

• 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: 10865231
• MDR Text Key: 217072879
• Report Number: 1917413-2020-01167
• 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: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 364956
• Device Catalogue Number: 364956
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1