MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367921

Device Problem Separation Failure (2547)

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

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

G5: pma/510(k)#: k945952, k901449.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® sodium fluoride potassium oxalate (fx) blood collection tubes on an automated instrument, the hemogard cap is removed while the inner rubber stopper remains stuck on the tube.The issue occurred 1 time.There was no health impact or consequences reported.

Event Description

It was reported when using the bd vacutainer® sodium fluoride potassium oxalate (fx) blood collection tubes on an automated instrument, the hemogard cap is removed while the inner rubber stopper remains stuck on the tube.The issue occurred 1 time.There was no health impact or consequences reported.

Manufacturer Narrative

H.6.Investigation summary: one hundred (100) retention samples from bd inventory were visually inspected with no issues observed.In addition, ten (10) retention samples were functionally tested for closure separation and no issues were identified.Thirty (30) retention samples were sent to franklin lakes for r&d testing.The test results were satisfactory.The ongoing investigation into customer closure separation (decapping) failures has made progress in the last few months.Two potential causes were identified, and product has been manufactured under different experimental conditions to evaluate these potential causes.These product samples are being tested to verify key factors in production that may contribute to the separation of the stopper from the cap in automation lines feeding into tube analyzers.We also identified that our testing method required improvement to better reflect the dynamics and forces seen at the decapping step in tube automation lines.This method has been released and is being tested in parallel with historic methods to verify effectiveness in replicating the field failures.To date it has been able to better reflect the performance seen at our customer sites and we are moving to fully validate it for use on our design specifications in the future.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 is unable to be confirmed for the indicated failure mode, closure separation.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 POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18529340
• MDR Text Key: 333251632
• Report Number: 1917413-2024-00016
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679213
• UDI-Public: (01)50382903679213
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K945952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 367921
• Device Lot Number: 2292096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1