BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ GRAVITY INFUSION SET

    MDR report key: 16403107 · Received February 20, 2023

    Report

    Report Number
    2243072-2023-00245
    Event Type
    Malfunction
    Date Received
    February 20, 2023
    Date of Event
    January 25, 2023
    Report Date
    March 10, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 16-FEB-2023. H6: INVESTIGATION SUMMARY: TWO 03501412321HN SAMPLES WERE RECEIVED FOR INVESTIGATION; ONE SAMPLE WAS RECEIVED WITHOUT PACKAGING, AND THE OTHER WAS RECEIVED IN SEALED PACKAGING FROM LOT 20220517. A VISUAL INSPECTION CONFIRMED THE CUSTOMER'S EXPERIENCE AS THE MALE LUER OF THE SAMPLE RECEIVED WITHOUT PACKAGING WAS IDENTIFIED TO HAVE BEEN RETURNED SEPARATED FROM THE TUBING; SOME RESIDUAL SOLVENT WAS VISIBLE AT THE TUBING OF THE AFFECTED JOINT. NO MANUFACTURING DEFECTS OR DAMAGE WERE VISIBLE TO THE SECOND SAMPLE RECEIVED IN SEALED PACKAGING. THE SAMPLE IN SEALED PACKAGING WAS THEN SENT TO THE BD PRODUCT TEST LABORATORY FOR TENSILE TESTING IN ACCORDANCE WITH THE REQUIREMENTS INFUSION EQUIPMENT FOR MEDICAL USE. FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT. THE PRODUCT MET THE TENSILE REQUIREMENTS OF THE STANDARD. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE LEGAL MANUFACTURER, ANHUI TIANKANG MEDICAL PRODUCTS CO.,LTD, FOR INVESTIGATION. THEY CONFIRMED THAT THE SEPARATION IS LIKELY TO HAVE OCCURRED AS A RESULT OF AN INSUFFICIENT AMOUNT OF SOLVENT HAVING BEEN APPLIED TO THE TUBING DURING THE SOLVENT BONDING PROCESS; THIS IS A MANUALLY PERFORMED ASSEMBLY STEP AND IS LIKELY TO HAVE OCCURRED DUE TO HUMAN ERROR. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 20220517 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS HANSCENT. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ GRAVITY INFUSION SET SEPARATED FROM THE INFUSION LINE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "LUER CONNECTION FOR THE CONNECTION TO THE PVK HAS SEPARATED FROM THE TUBING... THE CONNECTOR (LUER LOCK CONNECTION) SEPARATED FROM THE INFUSION LINE WITHOUT ANY FORCE FROM THE USER. BY DIRECTLY OBSERVING THE INCIDENT, PATIENT HARM COULD BE AVERTED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ GRAVITY INFUSION SET SEPARATED FROM THE INFUSION LINE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "LUER CONNECTION FOR THE CONNECTION TO THE PVK HAS SEPARATED FROM THE TUBING. THE CONNECTOR (LUER LOCK CONNECTION) SEPARATED FROM THE INFUSION LINE WITHOUT ANY FORCE FROM THE USER. BY DIRECTLY OBSERVING THE INCIDENT, PATIENT HARM COULD BE AVERTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228621 BD¿ GRAVITY INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 20220517

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown