MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367983

Device Problems Deformation Due to Compressive Stress (2889); Separation Problem (4043)

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

Event Date 10/13/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).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 that while using bd vacutainer® sst¿ blood collection tubes, the rubber stopper remained in the tube and when the cover was removed manually, the top of the blood collection tube had molding defect (non-cosmetic) as if it was melted at high temperature.This event occurred 3 times and no report of adverse or injury.

Manufacturer Narrative

The following information has been updated with corrected and/or additional information: imdrf annex a grid: a1503 - separation problem (2906) h.6.Investigation summary: bd received five(5) photos from the customer in support of this complaint.After review and analysis of the customer photos, the hemogard shield is not intact as the stopper remains within the tube.A molding defect is also observed at the top of the tube.Additionally, thirty(30) retain samples were visual inspected for any subjected damages or molding defects.0 of 30 retain samples failed.Forty three(43) retained samples were sent to franklin lakes for r&d testing.Bd was able to confirm the customer¿s indicated failure mode based on the photograph provided, however, r&d retained samples (43) test results were satisfactory.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.Additionally, the ongoing investigation into customer closure separation (decapping) failures has made progress in the last few months.Bd performed a thorough investigation into this issue utilizing root cause analysis tools.Bd identified two potential root causes, and product was manufactured under different experimental conditions to evaluate the potential causes.The product samples were tested to verify key factors in production that may contribute to the separation of the cap from the stopper in automation lines delivering tubes to analyzers.During root cause analysis sessions and testing, bd identified our internal testing method for stopper function required improvement to better reflect the dynamics and forces seen at the decapping step in tube automation lines.This method has been released and continues to be 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.To date bd has not been able to identify a definitive root cause, but our r&d team will continue to investigate complaints for this defect.A complaint history review was conducted, and no trends were identified.Based on the severity and occurrence rate of this issue no corrective action will be taken at this time.Complaints received for this device and reported conditions will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for the identification of emerging trends.

Event Description

It was reported that while using bd vacutainer® sst¿ blood collection tubes, the rubber stopper remained in the tube and when the cover was removed manually, the top of the blood collection tube had molding defect (non-cosmetic) as if it was melted at high temperature.This event occurred 3 times and no report of adverse or injury.

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18112242
• MDR Text Key: 328630478
• Report Number: 1024879-2023-00808
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679831
• UDI-Public: (01)50382903679831
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: BK050036
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 367983
• Device Lot Number: 3067281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2023
• 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