BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTOR P50 MULTIPACK

    MDR report key: 10411631 · Received August 14, 2020

    Report

    Report Number
    3003152976-2020-00365
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    July 22, 2020
    Report Date
    November 3, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    50382905151069
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/30/2020. H.6. INVESTIGATION: TWO PROTECTORS CONNECTED TO A VIAL, ONE INJECTOR ATTACHED TO A SYRINGE, AND TWO ADDITIONAL SYRINGES WERE RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. AFTER VISUAL INSPECTION, THERE WAS NO DEFECTS IDENTIFIED ON THE MEMBRANE OF THE PROTECTOR AND THE PROTECTOR WAS VERIFIED TO HAVE PROPERLY PENETRATED TO THE VIAL STOPPER. GREY PARTICLES WERE OBSERVED INSIDE THE VIALS ALONG WITH SEVERAL CRYSTALIZED SUBSTANCES OBSERVED INSIDE THE SYRINGES. CHARACTERIZATION TESTING WAS PERFORMED ON THE PARTICLES AND IDENTIFIED THEM TO BE CONSISTENT WITH THE RUBBER STOPPER OF THE VIAL. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2001112, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THESE ISSUES. FRAGMENTATION TESTING IS PERFORMED ACCORDING TO PROCEDURE, TO EVALUATE ANY PARTICULATES GENERATED AFTER TEN ACTIVATIONS. RESULTS WERE REVIEWED FOR THE REPORTED LOT AND FOUND TO BE WITHIN SPECIFICATION. BASED ON THE AVAILABLE WE ARE NOT ABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROTECTOR P50 MULTIPACK EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ETOPOSIDE: CORING WAS FOUND IN 1 OF 2 SYRINGES.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROTECTOR P50 MULTIPACK EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ETOPOSIDE: CORING WAS FOUND IN 1 OF 2 SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870236 PROTECTOR P50 MULTIPACK PHASEAL PROTECTOR ONB BECTON DICKINSON, S.A. 515106 2001112 50382905151069

    Patients

    Seq Age Sex Outcome Treatment
    1 Other