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 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9241980.Medical device expiration date: 2021-02-28.Device manufacture date: 2019-08-29.Medical device lot #: 9184874.Medical device expiration date: 2020-12-31.Device manufacture date: 2019-07-03.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 erroneous results were found during use with a bd vacutainer® urine analysis preservative tube.The following information was provided by the initial reporter, "-it is reported by customer urinalysis instrument alerted crystals being present in specimen.Though upon manual inspection customer confirmed specimen had no crystals present."notification by urinalysis instrument of presence of crystals; when examined microscopically, no crystals present.Customer uses arkray au4050 for urinalysis testing.They started transferring specimens in the ua department to the uap tube and immediately running them on their instrument.They started receiving crystal notifications, requiring them to review the specimen microscopically, where they then saw no crystals present." during the survey he stated that the tiger top tubes for urine show crystals in it.That is, it shows falls (+) positive for crystals." 10 occurrences were reported.

Event Description

It was reported that erroneous results were found during use with a bd vacutainer® urine analysis preservative tube.The following information was provided by the initial reporter."it is reported by customer urinalysis instrument alerted crystals being present in specimen.Though upon manual inspection customer confirmed specimen had no crystals present."notification by urinalysis instrument of presence of crystals; when examined microscopically, no crystals present.Customer uses arkray au4050 for urinalysis testing.They started transferring specimens in the ua department to the uap tube and immediately running them on their instrument.They started receiving crystal notifications, requiring them to review the specimen microscopically, where they then saw no crystals present." during the survey he stated that the tiger top tubes for urine show crystals in it.That is, it shows falls (+) positive for crystals." 10 occurrences were reported.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation.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.H3 other text : see section h.10.

• 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: 9701807
• MDR Text Key: 188052667
• Report Number: 1917413-2020-00110
• 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: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 364992
• Device Lot Number: SEE. H.10
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other