MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367958

Device Problem Separation Failure (2547)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

B3.Date of event is unknown.The date received by manufacturer has been used for this field.H3.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 during use with the bd vacutainer® sst¿ ii advance plus blood collection tubes, the rubber stopper remained in the tube when the cap was removed.There was no report of patient impact.

Event Description

It was reported that during use with the bd vacutainer® sst¿ ii advance plus blood collection tubes, the rubber stopper remained in the tube when the cap was removed.There was no report of patient impact.

Manufacturer Narrative

H.6.Investigation summary: bd received one(1) video from the customer in support of this complaint.Thirty(30) 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 video provided, however, r&d retained samples (30) 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.H3 other text : see h.10.

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18936048
• MDR Text Key: 338188567
• Report Number: 9617032-2024-00402
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 30382903679585
• UDI-Public: (01)30382903679585
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: NA
• 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
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367958
• Device Lot Number: 3151543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2023
• 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