BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH LUER ADAPTER

    MDR report key: 7058773 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00783
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 9, 2015
    Report Date
    October 31, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5072515. ONE CUSTOMER SAMPLE RECEIVED FOR INSPECTION. VISUAL INSPECTION OF THE SAMPLE IDENTIFIED A SMALL AMOUNT OF SOLVENT INSIDE FEMALE LUER. CONCLUSION: THE SOLVENT IS BELIEVED TO HAVE MIGRATED INSIDE THE LUER DURING BONDING OF THE LUER TO THE TUBING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER CONFIRMATION OF ADAPTER AND LUER CONNECTION THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH LUER ADAPTER 23 G X 0.75 IN. STILL LEAKED BLOOD. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838753 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH LUER ADAPTER BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) 5072515

    Patients

    Seq Age Sex Outcome Treatment
    1 Other