BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH LUER ADAPTER 23G X 0.75"

    MDR report key: 6697897 · Received July 10, 2017

    Report

    Report Number
    1024879-2017-00087
    Event Type
    Malfunction
    Date Received
    July 10, 2017
    Date of Event
    June 16, 2017
    Report Date
    September 11, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K980414
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    TWO LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6342930, MEDICAL DEVICE EXPIRATION DATE: 11/30/2018, DEVICE MANUFACTURE DATE: 12/7/2016. MEDICAL DEVICE LOT #: 7081782, MEDICAL DEVICE EXPIRATION DATE: 3/31/2019, DEVICE MANUFACTURE DATE: 3/22/2017. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. UDI #: (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CATALOG NUMBER: 367284. BATCH NUMBER: 7081782. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THIS BATCH. ALL INSPECTIONS WERE IN COMPLIANCE WITH REQUIREMENTS. CUSTOMER SAMPLE/PHOTO ANALYSIS: PHOTOS SHOW A PREVIOUSLY USED SLBCS SAMPLE WITH THE NEEDLE PROTRUDING FROM THE SIDE OF THE SAFETY SHIELD. NINETEEN CUSTOMER SAMPLES WERE EVALUATED FOR BREAKAWAY, SUSTAINING, AND SECURITY FORCES. ALL FORCE MEASUREMENTS MET SPECIFICATION WHEN TESTED IN ACCORDANCE WITH (B)(4) AND (B)(4). BREAKAWAY FORCE: THE FORCE REQUIRED TO START MOVING THE WING OUT OF ITS EXTENDED POSITION (FRONT GROOVE) SUSTAINING FORCE: THE FORCE REQUIRED TO SMOOTHLY MOVE THE WING ALONG THE SLOT BETWEEN THE SAFETY SHIELD TO ITS RETRACTED POSITION (REAR GROOVE). SECURITY FORCE: THE FORCE REQUIRED TO DISENGAGE THE WING FROM THE RETRACTED POSITION (REAR GROOVE). CATALOG NUMBER: 367284. BATCH NUMBER: 6342930. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THIS BATCH. ALL INSPECTIONS WERE IN COMPLIANCE WITH REQUIREMENTS. CUSTOMER SAMPLE/PHOTO ANALYSIS: NO PHYSICAL/PHOTO SAMPLES WERE RECEIVED. INVESTIGATION ROOT CAUSE SUMMARY: WE ACKNOWLEDGE THAT THE CUSTOMER HAD AN ISSUE WITH SLBCS PRODUCT IN REVIEW OF A CUSTOMER SUBMITTED PHOTO. HOWEVER, NO ROOT CAUSE FROM THE MANUFACTURING PROCESS WAS IDENTIFIED AS A CONTRIBUTOR TO THE REPORTED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY SHIELD OF A BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH LUER ADAPTER 23 G X 0.75 IN. DID NOT COVER THE ENTIRE NEEDLE POST USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477727 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH LUER ADAPTER 23G X 0.75" BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other