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 12/10/2019

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 an unspecified number of bd vacutainer® urine analysis preservative tubes experienced erroneous results prior to use.The following information was provided by the initial reporter: material no.364992.Batch no.9184874.Customer did an evaluation for preservative ua tubes vs non preservative ua tube.Customer is confused about the method comparison.They believe the method comparison should have better correlation.They do not understand the method is a sim-quantitative method.

Event Description

It was reported that an unspecified number of bd vacutainer® urine analysis preservative tubes experienced erroneous results prior to use.The following information was provided by the initial reporter: material no.364992, batch no.9184874.Customer did an evaluation for preservative ua tubes vs non preservative ua tube.Customer is confused about the method comparison.They believe the method comparison should have better correlation.They do not understand the method is a sim-quantitative method.

Manufacturer Narrative

H.6.Investigation: 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.Clsi guidelines indicate a sample size of at least 20 for this process.The customer has indicated a sample size of only 4 for this method comparison.In addition, it may be helpful to set a threshold preservative level in this situation because of the nature of these sample types that are being compared and potential background issues that may be encountered.

• 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: 9537295
• MDR Text Key: 188062000
• Report Number: 1917413-2019-02588
• 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: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 364992
• Device Lot Number: 9184874
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other