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

Model Number 364956

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

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 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
• Type of Device: 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
• MDR Text Key: 318400577
• Report Number: 1917413-2023-00631
• Device Sequence Number: 1
• Product Code: JSM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1