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 02/27/2020

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 during use the bd vacutainer® urine analysis preservative tube experienced erroneous results.This event occurred on 8 occasions.The following information was provided by the initial reporter: "false positive protein results from urinalysis tube with preservative.False positive results are coming from our patient clinics".

Event Description

It was reported during use the bd vacutainer® urine analysis preservative tube experienced erroneous results.This event occurred on 8 occasions.The following information was provided by the initial reporter: "false positive protein results from urinalysis tube with preservative.False positive results are coming from our patient clinics".

Manufacturer Narrative

H.6.Investigation: bd received 27 samples and 1 photo from the customer for investigation.The photos were reviewed and the customer¿s indicated failure mode for erroneous results with the incident lot was not observed.No further testing could be completed on the contaminated tubes.The product has been manufactured correctly per the specification.The instrument manufacturer (beckman / arkray) has indicated that they have published data regarding this product (ref 364992) and protein interference with their methodology in a selected group at initial collection.It is also noted that there may have been inadequate mixing of the samples after collection.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality non-conformances during manufacturing of the product.

• 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: 9868326
• MDR Text Key: 186703490
• Report Number: 1917413-2020-00321
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 364992
• Device Lot Number: 9241980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other