BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X50 PR CLEAR LEAF PFE PUURS

    MDR report key: 8565159 · Received April 30, 2019

    Report

    Report Number
    3001741852-2019-00010
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    April 12, 2019
    Report Date
    May 17, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    MEG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THIS BATCH WAS MANUFACTURED BY A MOULDING SUPPLIER. BDM-PS PERFORMED A REVIEW OF THE RELEASE DOCUMENTS AND THE BATCH MET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WAS MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. NO SAMPLES WERE RETURNED. BASED ON THE INVESTIGATION CONCLUSION, BDM-PS WAS ABLE TO CONFIRM THE DETECTION AND CHARACTERIZE THE CONDITION REPORTED BY THE CUSTOMER. THE REPORTED CONDITION, HAS BEEN CONFIRMED TO BE WITHIN THE SPECIFIED ACCEPTABLE QUALITY LEVEL (AQL¿S) DEFINED IN THE APPLICABLE SPECIFICATION. THE INCOMPLETE TIPS ON THE PLUNGER RODS ARE CAUSED BY SHORT SHOTS WHEN INSUFFICIENT MATERIAL IS INJECTED INTO THE MOULD. THIS DEFECT IS USUALLY CAUSED DUE TO A BUILD-UP OF DEGRADED MATERIAL IN THE BARREL AND MOULD HOT RUNNER SYSTEM WHICH, IN TIME, MOVES UP TO THE GATES IN THE TOOL RESULTING IN A BLOCKAGE. THE BLOCKAGE THEN PREVENTS THE CAVITY BEING FILLED AND ENDS UP PRODUCING INCOMPLETE COMPONENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 21 ULTRASAFE X50 PR CLEAR LEAF PFE PUURS PLUNGER RODS WERE FOUND DAMAGED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FAULTY PLUNGERRODS".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 21 ULTRASAFE X50 PR CLEAR LEAF PFE PUURS PLUNGER RODS WERE FOUND DAMAGED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FAULTY PLUNGERRODS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360527 ULTRASAFE X50 PR CLEAR LEAF PFE PUURS NEEDLE GUARD MEG BECTON DICKINSON 1797934

    Patients

    Seq Age Sex Outcome Treatment
    1 Other