MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® URINALYSIS URINE TUBE

Catalog Number	364979
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results - bd received samples and photos from the customer facility for investigation.The samples and photos were evaluated and the customer¿s indicated failure mode for foreign matter with the incident lot was observed.Additionally, a review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion - based on the investigation, a root cause could not be determined within the scope of this evaluation.The fm was identified as blood through pcr analysis by r&d; however, the source of the blood could not be traced back to any issues during manufacturing.
Event or Problem Description
It was reported that bd vacutainer® urinalysis urine tube had foreign matter on the stopper.No injury or medical intervention reported.

• Brand Name: BD VACUTAINER® URINALYSIS URINE TUBE
• Common Device Name: BD VACUTAINER® URINALYSIS URINE TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7431422
• Report Number: 1917413-2018-00814
• Device Sequence Number: 1339574
• Product Code: KDT
• 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
• Report Date (Section B): 04/13/2018

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: 09/30/2018
• Device Catalogue Number: 364979
• Device Lot Number: 6253615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2017
• Initial Report FDA Received Date: 04/13/2018
• 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