MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD KIT URIN CUP PLC 16X100 10.0 UA YEL; URINE COLLECTION DEVICE

Catalog Number	364981
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter state: address information was not able to be obtained.(b)(6) was used as based off the area code.Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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-conformance's during manufacturing of the product.
Event or Problem Description
It was reported that during use there was issue of under-filling with a bd kit urin cup plc 16x100 10.0 ua yel.The following information was provided by the initial reporter: it is reported customer was experiencing difficulty using and/or under-filling of vacutainer in urine collection kit sent by customer¿s insurance company.

• Brand Name: BD KIT URIN CUP PLC 16X100 10.0 UA YEL
• Common Device Name: URINE COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 9119341
• Report Number: 1917413-2019-02128
• Device Sequence Number: 11295454
• Product Code: JTW
• UDI-Device Identifier: 00382903649815
• UDI-Public: 00382903649815
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K790366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2019

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: 08/31/2020
• Device Catalogue Number: 364981
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 09/25/2019
• 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