BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P14

    MDR report key: 14960470 · Received July 8, 2022

    Report

    Report Number
    3003152976-2022-00313
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    May 18, 2022
    Report Date
    September 26, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905151002
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EXPIRATION DATE: UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 12-JUL-2022. INVESTIGATION SUMMARY: ONE SAMPLE PROTECTOR WAS RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. FUNCTIONAL TESTING WAS COMPLETED, PASSING LIQUID THROUGH THE INJECTOR INTO THE VIAL, IT WAS NOTED THAT THE FILTER OF THE PROTECTOR WAS SATURATED. NO LEAKAGE OUTSIDE OF THE PROTECTOR WAS IDENTIFIED, HOWEVER, LIQUID WAS OBSERVED INSIDE THE EXPANSION CHAMBER. IF THE PROTECTOR IS USED MORE THAN ONCE, LIQUID MAY ACCUMULATE AND OVERSATURATE THE FILTER. THIS OVERSATURATION WOULD CREATE A PRESSURE WHICH PREVENTS PROPER AIR RELEASE TO THE EXPANSION CHAMBER. THE SAME EFFECT MAY OCCUR IF LIQUID ACCUMULATED WITHIN THE INTERNAL FACE OF THE VIAL RUBBER STOPPER, OVERPRESSURE CAN THEN CREATE A LEAK INTO THE EXPANSION CHAMBER. PRODUCTS UNDERGO VISUAL AND FUNCTIONAL TESTING THROUGHOUT MANUFACTURING TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION AND THE EXPANSION CHAMBER IS PROPERLY POSITIONED AND WELDED. AS THE LOT INVOLVED IN THIS INCIDENT IS UNKNOWN, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. BASED ON THE QUALITY TEAM'S INVESTIGATION, A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P14 EXPERIENCED AN EXPANSION CHAMBER THAT BURST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE USING PHASEAL PROTECTORP14 CORRECTLY, IT SPLIT CYTOSTATIC WITH FORCE TO HDW¿S HANDS. WHEN DRAWN DRUG FROM THE BOTTLE, THE BALLOON EXPLODED AND ALL DRUG SPILLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P14 EXPERIENCED AN EXPANSION CHAMBER THAT BURST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE USING PHASEAL PROTECTORP14 CORRECTLY, IT SPLIT CYTOSTATIC WITH FORCE TO HDW¿S HANDS. WHEN DRAWN DRUG FROM THE BOTTLE, THE BALLOON EXPLODED AND ALL DRUG SPILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086563 BD PHASEAL¿ PROTECTOR P14 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. UNKNOWN 00382905151002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown