BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSEMBLY FIXTURE M12-O

    MDR report key: 10665233 · Received October 12, 2020

    Report

    Report Number
    2243072-2020-01637
    Event Type
    Malfunction
    Date Received
    October 12, 2020
    Date of Event
    September 17, 2020
    Report Date
    January 15, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    ONB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 1910001 D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-12-17 H4: DEVICE MANUFACTURE DATE: 2020-04-10 H6: INVESTIGATION SUMMARY ONE UNIT AND ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE PHOTO, THE STOPPER IS OBSERVED TO BE PUSHED INTO THE VIAL. FUNCTIONAL EVALUATIONS WERE PERFORMED, USING BOTH A 20 MM VIAL AND 13 MM VIAL. IN BOTH CASES THE PROTECTORS WERE ASSEMBLED ONTO A VIAL WITHOUT ISSUE, THE SPIKE PROPERLY ALIGNED WITH THE MIDDLE OF THE STOPPER. DURING OUR EVALUATIONS IT WAS NOTED WITH THE P13-O PROTECTOR, IF THE PROTECTOR MEMBRANE CAP WAS SLIGHTLY ASKEW FROM THE PROTECTOR BODY, THE ALIGNMENT OF THE SPIKE AND VIAL IS AFFECTED. DUE TO SMALL SIZE OF THE STOPPER, IF THE PROTECTOR SPIKE IS MISALIGNED AND STILL ABLE TO PENETRATE THE STOPPER, IT MAY CAUSE THE STOPPER TO BECOME DISTORTED. A REVIEW OF DEVICE RECORDS WAS PERFORMED FOR LOT 1910001, ALL PRODUCT WAS VERIFIED TO BE MANUFACTURED ACCORDING TO SPECIFICATION. PRODUCT UNDERGOES 100% INSPECTION BEFORE RELEASE, NO ISSUES WERE IDENTIFIED RELATED TO THE REPORTED FAILURE. BASED ON THE INVESTIGATION, A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE IDENTIFIED AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF ASSEMBLY FIXTURE M12-O EXPERIENCED VIAL BREAKAGE DURING ASSEMBLY OF PROTECTOR TO VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515082 BATCH NO: 1910001 COMPLAINT 2 OF 2 EVENT DESCRIPTION: THIS OCCURRED WHEN THE VIAL WAS PUNCTURED WITH THE P13 PROTECTOR USING THE OPTIMA ASSEMBLY FIXTURE. PER REP AFTER FURTHER INVESTIGATION, THE ASSEMBLY FIXTURE CAUSED THE ISSUE; PRODUCT CODE 515082 THE CUSTOMER THREW THE BOX AWAY SO WE ARE UNSURE WHAT THE LOT # OF THE FIXTURE IS.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER ZIP CODE: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF ASSEMBLY FIXTURE M12-O EXPERIENCED VIAL BREAKAGE DURING ASSEMBLY OF PROTECTOR TO VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515082 BATCH NO: UNKNOWN. COMPLAINT 2 OF 2. EVENT DESCRIPTION: THIS OCCURRED WHEN THE VIAL WAS PUNCTURED WITH THE P13 PROTECTOR USING THE OPTIMA ASSEMBLY FIXTURE. PER REP AFTER FURTHER INVESTIGATION, THE ASSEMBLY FIXTURE CAUSED THE ISSUE; PRODUCT CODE 515082. THE CUSTOMER THREW THE BOX AWAY SO WE ARE UNSURE WHAT THE LOT # OF THE FIXTURE IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131480 ASSEMBLY FIXTURE M12-O ASSEMBLY FIXTURE ONB BECTON DICKINSON 1910001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other