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

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	02/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.(b)(6).Investigation summary: bd had not received samples, but photos were provided by your facility for investigation.The photos were evaluated and the indicated failure mode for foreign matter with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Bd is continually monitoring complaints received for this device and reported condition in order to identify emerging trends.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for foreign matter with the incident lot was observed.Root cause description: based on the investigation, a root cause could not be determined.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that before use of the bd vacutainer® urinalysis urine tube there was black foreign matter found inside the tube.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples, but photos were provided by your facility for investigation.The photos were evaluated and the indicated failure mode for foreign matter with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Bd is continually monitoring complaints received for this device and reported condition in order to identify emerging trends.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for foreign matter with the incident lot was observed.Root cause description: based on the investigation, a root cause could not be determined.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that before use of the bd vacutainer® urinalysis urine tube there was black foreign matter found inside the tube.

• Brand Name: BD VACUTAINER® URINALYSIS URINE TUBE
• 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: 8401256
• Report Number: 1917413-2019-00947
• Device Sequence Number: 1858564
• Product Code: KDT
• UDI-Device Identifier: 00382903649792
• UDI-Public: 00382903649792
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2019

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: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 364979
• Device Lot Number: 8156641
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 03/08/2019
• 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