BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTOR P50 MULTIPACK

    MDR report key: 10411658 · Received August 14, 2020

    Report

    Report Number
    3003152976-2020-00370
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    July 20, 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 VIALS WERE RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, THERE WAS NO DEFECTS IDENTIFIED ON THE MEMBRANE OF THE PROTECTOR AND THE PROTECTOR WAS VERIFIED TO HAVE PROPERLY PENETRATED TO THE VIAL STOPPER. DURING OUR EVALUATION A GREY PARTICLE WAS OBSERVED INSIDE ONE OF THE VIALS . X-RAY ANALYSIS WAS PERFORMED AND IDENTIFIED THE PARTICLE TO BE CONSISTENT WITH THE ALUMINUM CAP 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. NO ROOT CAUSE RELATED TO OUR PROCESS COULD BE IDENTIFIED AT THIS TIME. WHEN A SPIKE OR NEEDLE PENETRATES A DRUG VIAL, /IV BOTTLE BAG STOPPER/PORT, THERE IS ALWAYS A POSSIBILITY OF CORING/FRAGMENTATION WITH THE PRODUCTION OF VISIBLE AND SUB-VISIBLE PARTICLES IN THE SOLUTION. DUE TO THIS KNOWN RISK, VARIOUS ORGANIZATIONS INCLUDING ASHP AND USP (797) HAVE ESTABLISHED ACCEPTABLE STANDARDS AND PRACTICE OF COMPOUNDING STERILE PRODUCTS (CSPS). THIS INCLUDES THE STANDARD FOR VISUAL INSPECTION OF THE MEDICATION VIAL, SYRINGE AND IV BAG PRIOR TO DISPENSING AND ADMINISTERING A COMPOUNDED STERILE PRODUCT. BASED ON THIS ASSESSMENT, IT WAS ESTABLISHED THAT CORING/FRAGMENTATION IS A KNOWN RISK FOR ALL CSPS, AND THAT VISUAL INSPECTION IS A STANDARD OF PRACTICE DURING CSPS AND ADMINISTRATION. THE RISK CANNOT BE REDUCED ANY FURTHER AND IS SIMILAR TO OTHER PRODUCTS IN THE MARKET. WITHIN THE PRACTICE OF CSPS, THIS IS A KNOWN RISK AND THE SAFETY BENEFITS OF USING CSTDS OUTWEIGHS THE POSSIBILITY OF CORING/FRAGMENTATION AND ASSOCIATED HEALTH RISKS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CORING WAS FOUND IN PROTECTOR P50 MULTIPACK. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HERCEPTIN: CORING WAS FOUND IN 1 OF 2 VIALS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CORING WAS FOUND IN PROTECTOR P50 MULTIPACK. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HERCEPTIN: CORING WAS FOUND IN 1 OF 2 VIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870269 PROTECTOR P50 MULTIPACK INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515106 2001112 50382905151069

    Patients

    Seq Age Sex Outcome Treatment
    1 Other