MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® URINE COLLECTION URINALYSIS CUP KIT: STERILE SCREW-CAP; COLLECTION CUP

Catalog Number	364989
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results - one hundred customer samples were returned.Twenty were observed for stopper creepout/pop off.The tubes sat and were visually inspected for creepout.The tubes were picked up by shield assemblies and shaken to see if the stopper would dislodge.Stopper creepout was not observed.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 4177818.Conclusion: bd was not able to duplicate or confirm the customers indicated failure mode.
Event or Problem Description
It was reported that the bd vacutainer® urine collection urinalysis cup kit: sterile screw-cap collection cup with integrated transfer device and 8.0 ml, 16x100 mm plus plastic conical tube for urinalysis had a stopper come off which resulted in a leak of urine into a biohazard bag.No injury or medical intervention was reported.
Additional Manufacturer Narrative
The initial mdr was submitted with the device type code as jsm.It is corrected to read kdt.The initial mdr was submitted with the 510k number listed as n/a.It is corrected to read exempt.

• Brand Name: BD VACUTAINER® URINE COLLECTION URINALYSIS CUP KIT: STERILE SCREW-CAP
• Common Device Name: COLLECTION CUP
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7059104
• Report Number: 1917413-2017-00235
• Device Sequence Number: 112061
• Product Code: KDT
• UDI-Device Identifier: 00382903649891
• UDI-Public: 00382903649891
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 364989
• Device Lot Number: 4177818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2015
• Initial Date Received by Manufacturer: 08/31/2015
• Supplement Date Received by Manufacturer: 08/31/2015
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other