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

Catalog Number	364956
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 7 bd vacutainer® urine complete cup kit experienced sample leakage during use/sample collection.The following information was provided by the initial reporter: material no.364956, batch no.9121872.Seven incident reports regarding this item last night about them leaking.I got one and filled it with water to try myself and it did leak, from end user.
Event or Problem Description
It was reported that 7 bd vacutainer® urine complete cup kit experienced sample leakage during use/sample collection.The following information was provided by the initial reporter: material no.364956, batch no.9121872.Seven incident reports regarding this item last night about them leaking.I got one and filled it with water to try myself and it did leak, from end user.
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.

• 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
• MDR Report Key: 9239824
• Report Number: 1917413-2019-02256
• Device Sequence Number: 3077937
• Product Code: JSM
• UDI-Device Identifier: 50382903649568
• UDI-Public: 50382903649568
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K024240
• Number of Events Summarized: 1
• Summary Report (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): 10/30/2019

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: Lay User/Patient
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 364956
• Device Lot Number: 9121872
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 10/30/2019
• 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