BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 9694515 · Received February 11, 2020

    Report

    Report Number
    3003152976-2020-00048
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 9, 2020
    Report Date
    February 20, 2020
    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
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE UNIT AND ONE PHOTO WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. VISUAL INSPECTION OF THE SAMPLE REVEALED THE SYRINGE TIP WAS BROKEN AND DETACHED FROM THE BARREL. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION OF LOT NUMBER 1909265 AND LOT 1911216 THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TIP AND THREAD VERIFICATION TESTS ARE PERFORMED WITHIN THE MANUFACTURING ENVIRONMENT ACCORDING TO PROCEDURE. RESULTS WERE REVIEWED FOR THE SUSPECTED LOTS AND ALL RESULTS WERE CONFIRMED TO BE WITHIN SPECIFICATIONS. THE AREAS WHERE PIECES RUN IN MANUFACTURING AREA ARE PROTECTED TO AVOID DAMAGE ON THE PRODUCT. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. BASED ON THE INVESTIGATION RESULTS, IT WAS DETERMINED THAT THE TIP BREAKAGE OCCURRED DUE TO OVER-SCREW DURING THE CONNECTION OF THE SYRINGE BY THE USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE TIP BROKE OFF DURING USE WHEN PREPARING MEDICATION. SALINE FROM THE SYRINGE WAS BEING FILLED INTO A "B.BRAUN EASYPUMP" AND THE BREAKAGE OCCURRED WHEN THE SYRINGE WAS DETACHED FROM THE PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN PREPARING MEDICATION AT THE PHARMACY, THE TIP OF THE 50 ML SYRINGE BREAKS. IT HAPPENS DURING A PROCEDURE WHERE SALINE FROM THE SYRINGE IS FILLED INTO A B.BRAUN EASYPUMP. THEY DISCOVERED IT WHEN THE SYRINGE WAS DETACHED FROM THE ADDITION PORT."

    Additional Manufacturer Narrative · 1

    MEDICAL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE TIP BROKE OFF DURING USE WHEN PREPARING MEDICATION. SALINE FROM THE SYRINGE WAS BEING FILLED INTO A "B.BRAUN EASYPUMP" AND THE BREAKAGE OCCURRED WHEN THE SYRINGE WAS DETACHED FROM THE PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN PREPARING MEDICATION AT THE PHARMACY, THE TIP OF THE 50 ML SYRINGE BREAKS. IT HAPPENS DURING A PROCEDURE WHERE SALINE FROM THE SYRINGE IS FILLED INTO A B.BRAUN EASYPUMP. THEY DISCOVERED IT WHEN THE SYRINGE WAS DETACHED FROM THE ADDITION PORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160297 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other