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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter state: address information was not able to be obtained.(b)(6) was used as a place holder based on the user area code.(b)(4).Investigation summary: bd had not received samples or photos from the customer for evaluation.Based on a review of the device history record for the incident lot, 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 the tube under filled during use with a bd kit urin cup plc 16x100 10.0 ua yel.The following information was provided by the initial reporter: it was reported that the tube was not filling.

• 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: 10471768
• Report Number: 1917413-2020-00770
• Device Sequence Number: 19669291
• Product Code: KDT
• UDI-Device Identifier: 00382903649815
• UDI-Public: 00382903649815
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 08/14/2020

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 Expiration Date: 03/31/2022
• Device Catalogue Number: 364981
• Device Lot Number: 0057623
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 08/31/2020
• 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