BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET

    MDR report key: 7438715 · Received April 17, 2018

    Report

    Report Number
    9617032-2018-00477
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    October 21, 2016
    Report Date
    October 2, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: PATIENT IDENTIFIER CHANGED TO (B)(6). DATE OF EVENT CHANGED TO (B)(6) 2016 OTHER DETAILS CHANGED TO TUBES PUSH BACK FROM LUER ADAPTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED. DESCRIBE EVENT OR PROBLEM CHANGED TO IT WAS REPORTED THAT THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET HAD TUBE PUSH BACK. MEDICAL DEVICE BRAND NAME CHANGED TO BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET. MEDICAL DEVICE TYPE CHANGED TO N/A. MEDICAL DEVICE CATALOG # CHANGED TO 367282. MEDICAL DEVICE LOT # CHANGED TO 6032706. MEDICAL DEVICE MANUFACTURER CHANGED TO BECTON, DICKINSON & CO., (BD). MEDICAL DEVICE EXPIRATION DATE CHANGED TO 01/31/2018. UNIQUE IDENTIFIER (UDI) # CHANGED TO (B)(4). DEVICE AVAILABLE FOR EVAL CHANGED TO YES. DEVICE RETURNED TO MANUFACTURER CHANGED TO 10/28/2016. INITIAL REPORTER FIRST NAME CHANGED TO (B)(6). INITIAL REPORTER LAST NAME CHANGED TO (B)(6). INITIAL REPORTER ADDR 1 CHANGED TO UNKNOWN. INITIAL REPORTER CITY CHANGED TO (B)(6). INITIAL REPORTER COUNTRY CODE CHANGED TO GERMANY. INITIAL REPORTER FACILITY NAME CHANGED TO (B)(6) INSTITUT. MANUFACTURING LOCATION CHANGED TO BECTON, DICKINSON & CO., (BD). REPORT SOURCE OTHER CHANGED TO N/A. DATE RECEIVED BY MANUFACTURER CHANGED TO 10/21/2016. PMA / 510(K)# CHANGED TO N/A. DEVICE RETURN TO MANUFACTURE CHANGED TO YES. DEVICE EVAL BY MANUFACTURER CHANGED TO YES. DEVICE MANUFACTURE DATE CHANGED TO 02/08/2016. USAGE OF DEVICE CHANGED TO INITIAL. INVESTIGATION SUMMARY: TEN CUSTOMER SAMPLES WERE RECEIVED FOR EVALUATION. ALL TEN SLBCS SAMPLES WERE EVALUATED FOR TUBE PUSH OFF WITH 10 TUBES EACH. THERE WERE NO DEFECTS IDENTIFIED. DHR/BHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH 6032706 REORDER NUMBER 367282. PRODUCT WAS MANUFACTURED AT THE BD SUMTER SITE FEBRUARY 2016. ALL INSPECTIONS WERE IN COMPLIANCE WITH REQUIREMENTS. INVESTIGATION CONCLUSION: BASED ON A REVIEW OF THE DHR FOR THIS BATCH AND EVALUATION OF CUSTOMER RETURNED SAMPLES, WE ARE UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION 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 IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET HAD TUBE PUSH BACK.

    Additional Manufacturer Narrative · 1

    PHONE # UNKNOWN. FAX # UNKNOWN. RESULTS: A SAMPLE OR PHOTO IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PRESET¿ ECLIPSE¿ SPLATTERED BLOOD WHEN ACTIVATING SAFETY MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281003 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 6032706

    Patients

    Seq Age Sex Outcome Treatment
    1 Other