MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® URINALYSIS URINE TUBE; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number	364979
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Bd received samples and photos from the customer facility for investigation.This complaint is confirmed to be within the scope of a known issue.Quality has previously reviewed, evaluated and investigated this failure mode.No further action is required at this time.Based on evaluation of the complaint information, this complaint meets the criteria for a previously investigated complaint; reference (b)(4).
Event or Problem Description
It was reported that bd vacutainer® urinalysis urine tubes were collapsed.No report of serious injury or medical intervention.
Event or Problem Description
It was reported that bd vacutainer® urinalysis urine tubes were collapsed.No report of serious injury or medical intervention.
Additional Manufacturer Narrative
Additional information: the device history records for batch 7097784 have been reviewed with no issues being identified.

• Brand Name: BD VACUTAINER® URINALYSIS URINE TUBE
• Common Device Name: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7620735
• Report Number: 1917413-2018-01684
• Device Sequence Number: 1818970
• Product Code: JKA
• UDI-Device Identifier: 50382903649797
• UDI-Public: 50382903649797
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/06/2018

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: 04/30/2019
• Device Catalogue Number: 364979
• Device Lot Number: 7097784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 09/06/2018
• 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