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

Catalog Number 364979

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2016

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for erroneous results with the incident lot was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.

Event Description

It was reported that when using a bd vacutainer® urinalysis urine tube, false positive results for blood are received.There was no report of exposure, injury or medical intervention.

• Brand Name: BD VACUTAINER® URINALYSIS URINE TUBE
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7427902
• MDR Text Key: 105643052
• Report Number: 1917413-2018-00726
• Device Sequence Number: 1
• Product Code: KDT
• UDI-Device Identifier: 50382903649797
• UDI-Public: 50382903649797
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 364979
• Device Lot Number: 6090814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other