BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK SYRINGE

    MDR report key: 10111441 · Received June 2, 2020

    Report

    Report Number
    3003152976-2020-00235
    Event Type
    Malfunction
    Date Received
    June 2, 2020
    Date of Event
    May 13, 2020
    Report Date
    June 29, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PHOTO WAS VISUALLY INSPECTED AND NO SIGNS OF EXCESS SILICONE CAN BE OBSERVED INSIDE OR OUTSIDE OF THE BARREL. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1912280, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THIS ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS . LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER ACCORDING TO PROCEDURE, RESULTS WERE REVIEWED FOR THE REPORTED LOT AND FOUND TO BE WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A "GREASY" LAYER OF FOREIGN MATTER WAS VISIBLE INSIDE THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: WE HAVE BEEN USING THIS SYRINGE FOR A LONG TIME WITHOUT PROBLEMS, WITH ONE OF THE CYTOSTATIC FILLERS, MITOMYCIN, A GREASY LAYER (SILICONE?) IS VISIBLE ON THE INSIDE OF THE SYRINGE. THIS IS REALLY NOT ON THE OUTSIDE, NOT TO WIPE OR SCRAPE OFF. I CANNOT SEND THIS SYRINGE BECAUSE OF THE RISKY CONTENT. WE TOOK THE REST OF THIS BATCH OF SYRINGES (12 PIECES) FROM THE PHARMACY SHELVES AND THEN USED ANOTHER LOT NUMBER WITHOUT ANY PROBLEMS.

    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 A "GREASY" LAYER OF FOREIGN MATTER WAS VISIBLE INSIDE THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WE HAVE BEEN USING THIS SYRINGE FOR A LONG TIME WITHOUT PROBLEMS, WITH ONE OF THE CYTOSTATIC FILLERS, MITOMYCIN, A GREASY LAYER (SILICONE?) IS VISIBLE ON THE INSIDE OF THE SYRINGE. THIS IS REALLY NOT ON THE OUTSIDE, NOT TO WIPE OR SCRAPE OFF. I CANNOT SEND THIS SYRINGE BECAUSE OF THE RISKY CONTENT. WE TOOK THE REST OF THIS BATCH OF SYRINGES (12 PIECES) FROM THE PHARMACY SHELVES AND THEN USED ANOTHER LOT NUMBER WITHOUT ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571314 BD PLASTIPAK LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1912280

    Patients

    Seq Age Sex Outcome Treatment
    1 Other