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 10/11/2020

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 with the use of the bd vacutainer® urine complete cup kit there was under-fill or low draw of a tube with blood and sample leakage.The following information was provided by the initial reporter.The customer stated there was leakage when using urine cup as well as underfilling of c&s tube included in kit.The cups leak causing urine to spill all over the place.Bd team: reporting product concern.Product was not saved.".

Event Description

It was reported with the use of the bd vacutainer® urine complete cup kit there was under-fill or low draw of a tube with blood and sample leakage.The following information was provided by the initial reporter.The customer stated there was leakage when using urine cup as well as underfilling of c&s tube included in kit.The cups leak causing urine to spill all over the place.Bd team: reporting product concern.Product was not saved.".

Manufacturer Narrative

Investigation summary: bd had not received samples or photos 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.

• 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: 10865187
• MDR Text Key: 217072509
• Report Number: 1917413-2020-01164
• 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: 01/04/2021

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: 0093397
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1