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

Catalog Number 364992

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd vacutainer® urine analysis preservative tube produced false positive result for pregnancy test.Customer¿s verbatim: ¿ material no.(b)(6) batch no.8276625.It was reported the customer experienced false pregnancy test reading.Customer is inquiring if these tubes can create a false positive preg reading.¿.

Manufacturer Narrative

H.6.Investigation: investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Bd technical services conducted troubleshooting with the customer, and the customer indicated that the incorrect tube had been used for testing.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description: based on further information provided by the customer, the most likely root cause is that the customer used the incorrect tube for testing.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 Description

It was reported that a bd vacutainer® urine analysis preservative tube produced false positive result for pregnancy test.Customer¿s verbatim: ¿ material no.364992 batch no.8276625.It was reported the customer experienced false pregnancy test reading.Customer is inquiring if these tubes can create a false positive preg reading.¿.

• Brand Name: BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 8431840
• MDR Text Key: 139345168
• Report Number: 1917413-2019-01012
• Device Sequence Number: 1
• Product Code: KDT
• UDI-Device Identifier: 50382903649926
• UDI-Public: 50382903649926
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 364992
• Device Lot Number: 8276625
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other