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 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd vacutainer® urine analysis preservative tube experienced erroneous results.The following information was provided by the customer: material no.: 364992, batch/lot: unknown / not provided.It was reported that the customer is "seeing issues with the preservative tubes and using them for er patients when they are sent immediately and the preservative is not necessary." customer text: we are currently using the tiger top ua, and grey top with the blue cups.We are looking to see if it is an option for our facility to get a kit with the blue cup (364975), yellow top tube with no additive (364980), and the grey culture tube (364951) in one kit all together.We are seeing issues with the preservative tubes, and using them for er patients when they are sent immediately and the preservative is not necessary.

Event Description

It was reported that the bd vacutainer® urine analysis preservative tube experienced erroneous results.The following information was provided by the customer: material no.: 364992.Batch/lot: unknown / not provided it was reported that the customer is "seeing issues with the preservative tubes and using them for er patients when they are sent immediately and the preservative is not necessary." customer text: we are currently using the tiger top ua, and grey top with the blue cups.We are looking to see if it is an option for our facility to get a kit with the blue cup (364975), yellow top tube with no additive (364980), and the grey culture tube (364951) in one kit all together.We are seeing issues with the preservative tubes, and using them for er patients when they are sent immediately and the preservative is not necessary.

Manufacturer Narrative

Investigation: investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.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: as there was no sample or photo available for evaluation, 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.

• 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: 8492111
• MDR Text Key: 142635758
• Report Number: 1917413-2019-01134
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364992
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other