BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEM SS 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 11400392 · Received March 2, 2021

    Report

    Report Number
    2243072-2021-00673
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    December 24, 2020
    Report Date
    May 5, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION:DATE RECEIVED BY MANUFACTURER IS CORRECTED TO 2020-12-24 THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2021-02-02 INVESTIGATION SUMMARY ONE OE0420R SAMPLE WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION. A VISUAL INSPECTION OF THE RETURNED SAMPLE CONFIRMED THE CUSTOMER'S EXPERIENCE AS THE AIR VENT FILTER OF THE VIAL ACCESS DEVICE (VAD) WAS EASILY DETACHABLE. THE FILTER WAS PLACED BACK INTO THE VAD AND SUBJECTED TO FUNCTIONAL TESTING; LEAKAGE WAS OBSERVED FROM THE JOINT OF THE FILTER, CONFIRMING THE CUSTOMER'S EXPERIENCE. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. THEIR ANALYSIS IDENTIFIED THAT THE AIR VENT FILTER OF THE VAD APPEARED TO HAVE BEEN BROKEN OFF SUGGESTING THAT IT HAD BEEN SUBJECTED TO AN EXTERNAL FORCE, FURTHERMORE THERE WAS EVIDENCE OF GLUE AND MELTED PLASTIC SUGGESTING THAT IT HAD BEEN CORRECTLY ASSEMBLED PRIOR TO THE DAMAGE OCCURRING. A DEFINITIVE ROOT CAUSE FOR THE OBSERVED DAMAGE COULD NOT BE DETERMINED DURING THE INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 202047 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR LEAKED FROM THE OEM SS 20MM VENTED VIAL ACCESS DEVICE AT THE FILTER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE FOUND AN AIR LEAK AT THE FILTER CONNECTION. OCCURRENCE RATE 1/5 = 20% WITHSTAND A NEGATIVE AIR PRESSURE OF 12.5SPI. NON-CONFORMING AS IT EXCEEDS THE STANDARD OF AQL: 0.

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS YUKON. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: NA. 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 · 1

    IT WAS REPORTED THAT AIR LEAKED FROM THE OEM SS 20MM VENTED VIAL ACCESS DEVICE AT THE FILTER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE FOUND AN AIR LEAK AT THE FILTER CONNECTION. OCCURRENCE RATE 1/5 = 20% WITHSTAND A NEGATIVE AIR PRESSURE OF 12.5SPI. NON-CONFORMING AS IT EXCEEDS THE STANDARD OF AQL: 0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297816 OEM SS 20MM VENTED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 202047

    Patients

    Seq Age Sex Outcome Treatment
    1