MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD KIT URIN CUP PLC 16X100 10.0 UA YEL; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number	364981
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Initial reporter state: address information was not able to be obtained.(b)(6) was used as a place holder.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that tube does not draw in urine with a bd kit urin cup plc 16x100 10.0 ua yel.The following information was provided by the initial reporter: customer is a patient who received this kit.He states that the tube does not draw urine into the tube.Kit contained a absorbent sleeve to mail tube back in and he wanted to know how to get tube into sleeve.
Event or Problem Description
It was reported that tube does not draw in urine with a bd kit urin cup plc 16x100 10.0 ua yel.The following information was provided by the initial reporter: customer is a patient who received this kit.He states that the tube does not draw urine into the tube.Kit contained a absorbent sleeve to mail tube back in and he wanted to know how to get tube into sleeve.
Additional Manufacturer Narrative
H.6.Investigation summary.Bd had not received samples or photos from the customer for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.

• Brand Name: BD KIT URIN CUP PLC 16X100 10.0 UA YEL
• Common Device Name: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 10197255
• Report Number: 1917413-2020-00537
• Device Sequence Number: 2613691
• Product Code: KDT
• UDI-Device Identifier: 50382903649810
• UDI-Public: 50382903649810
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2020

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: Lay User/Patient
• Device Catalogue Number: 364981
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 07/13/2020
• 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