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

Model Number	364956
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with the bd vacutainer® urine complete cup kit, samples leaked out.There was no report of patient impact.The following information was provided by the initial reporter: customer states cups are leaking frequently and they had to stop using them.The staff would collect the urine and attempt to screw the cap back on the cup and had difficult with getting the cap to completely screw on.Did the specimen(s) need to be recollected? on occasion.Did exposure to blood/ bf occur? no.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6.Investigation summary: no samples or photos were returned by the customer in support of this complaint from catalog 364956, lot number is unknown.The retentions could not be inspected as the lot number is unknown.Bd was unable to duplicate or confirm the customer¿s indicated failure mode because no samples or photos were returned, and lot number is unknown.Lot number is unknown; therefore, no retention samples are available.The device history records could not be reviewed as the lot number is unknown.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that during use with the bd vacutainer® urine complete cup kit, samples leaked out.There was no report of patient impact.The following information was provided by the initial reporter: customer states cups are leaking frequently and they had to stop using them.The staff would collect the urine and attempt to screw the cap back on the cup and had difficult with getting the cap to completely screw on.Did the specimen(s) need to be recollected? on occasion.Did exposure to blood/ bf occur? no.If exposure occurred was there any post exposure testing or medical intervention? na.

• Brand Name: BD VACUTAINER® URINE COMPLETE CUP KIT
• Common Device Name: TRANSPORT CULTURE MEDIUM
• 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 ; 8448235433
• MDR Report Key: 17259424
• Report Number: 1917413-2023-00631
• Device Sequence Number: 7911658
• Product Code: JSM
• UDI-Device Identifier: 50382903649568
• UDI-Public: 50382903649568
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K024240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 364956
• Device Catalogue Number: 364956
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown