MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER SODIUM FLUORIDE: 3 MG. NA2 EDTA: 6MG; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367587

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/09/2021

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 when using the bd vacutainer® sodium fluoride: 3 mg.Na2 edta: 6mg, the device experienced foreign matter in tube; biological and non-biological.The following information was provided by the initial reporter.The customer stated: complaint from department of health.The customer complained that a fragment of a tube was found inside the tube.

Event Description

It was reported when using the bd vacutainer® sodium fluoride: 3 mg.Na2 edta: 6mg, the device experienced foreign matter in tube; biological and non-biological.The following information was provided by the initial reporter.The customer stated: complaint from department of health.The customer complained that a fragment of a tube was found inside the tube.

Manufacturer Narrative

Investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for foreign matter was observed.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 issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode foreign matter.Bd determined that the root cause of the indicated failure mode was attributed to a piece of broken tube that was introduced to an open tube on the production line before the operation that places the shield/stopper assembly on the tube.Corrective measures have been implemented to reduce foreign matter in the manufacturing facility.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VACUTAINER SODIUM FLUORIDE: 3 MG. NA2 EDTA: 6MG
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 12256168
• MDR Text Key: 264511783
• Report Number: 1917413-2021-00685
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903675871
• UDI-Public: 50382903675871
• Combination Product (y/n): N
• PMA/PMN Number: K945952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: 367587
• Device Catalogue Number: 367587
• Device Lot Number: 0316327
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1