BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK SYRINGE

    MDR report key: 8683833 · Received June 10, 2019

    Report

    Report Number
    3003152976-2019-00389
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    May 22, 2019
    Report Date
    August 9, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    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

    H.6. INVESTIGATION: ONE USED SAMPLE WAS RETURNED FOR INVESTIGATION. DUE TO THE PRODUCT BEING CONTAMINATED WITH HAZARDOUS MATERIAL, WE WERE NOT ABLE TO USE THE SAMPLE FOR EVALUATION. TEN RETAINED SAMPLES OF LOT 1903238 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, AND NO LEAK WAS IDENTIFIED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1903238, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YESTERDAY WE HAD A SPILL INCIDENT WITH A 20ML SYRINGE DURING THE PREPARATION OF PERJETA. THE LIQUID LEAKED ALONG THE BLACK RUBBER OF THE SYRINGE. BECAUSE OF THIS WE HAD TO OPEN A NEW BOTTLE OF PERJETA. COST: (B)(6)! THE SYRINGE IS ON MY DESK IN SEALED BAG IF THE COMPANY WANTS TO SEE IT. HOWEVER, I WOULD LIKE TO INFORM YOU THAT THE SYRINGE CONTAINS RESIDUE PERJETA (PERTUZUMAB, MONOCLONAL ANTIBODY)! THE LIQUID LEAKED FROM THE SYRINGE DURING PREPARATION. THE MAKER WAS WEARING GLOVES AND THE SYRINGE WAS PACKED IMMEDIATELY, THE GLOVES WERE CHANGED, THE STERILE FIELD WHERE THE LIQUID HAD BEEN LEAKED WAS REMOVED AND THE CABINET WAS CLEANED.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YESTERDAY WE HAD A SPILL INCIDENT WITH A 20ML SYRINGE DURING THE PREPARATION OF PERJETA. THE LIQUID LEAKED ALONG THE BLACK RUBBER OF THE SYRINGE. BECAUSE OF THIS WE HAD TO OPEN A NEW BOTTLE OF PERJETA. COST: 2920 EURO! THE SYRINGE IS ON MY DESK IN SEALED BAG IF THE COMPANY WANTS TO SEE IT. HOWEVER, I WOULD LIKE TO INFORM YOU THAT THE SYRINGE CONTAINS RESIDUE PERJETA (PERTUZUMAB, MONOCLONAL ANTIBODY)! THE LIQUID LEAKED FROM THE SYRINGE DURING PREPARATION. THE MAKER WAS WEARING GLOVES AND THE SYRINGE WAS PACKED IMMEDIATELY, THE GLOVES WERE CHANGED, THE STERILE FIELD WHERE THE LIQUID HAD BEEN LEAKED WAS REMOVED AND THE CABINET WAS CLEANED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477382 BD PLASTIPAK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1903238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other