BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 12484664 · Received September 16, 2021

    Report

    Report Number
    3003152976-2021-00603
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    August 20, 2021
    Report Date
    October 14, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY ONE SYRINGE AND PHOTOS RECEIVED FOR INVESTIGATION, SYRINGE WAS SENT DISASSEMBLED AND OUTSIDE ITS ORIGINAL UNITARY PACKAGING. UPON VISUAL INSPECTION, IT CAN BE SEEN DAMAGE IN BARREL, THERE IS A HIT BELOW NUMBER 30 OF THE SCALE. POSSIBLE ROOT CAUSE DUE TO PRODUCT JAMMED AGAINST ASSEMBLY EQUIPMENT DURING MANUFACTURING. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2012062 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE BARREL WAS NOTICED TO BE DAMAGED/"CRUSHED" WHILE DRAWING UP LIQUID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BARREL OF THE SYRINGE IS DAMAGED, IT LOOKS LIKE IT HAS BEEN CRUSHED AFTER THE PAD PRINTING BECAUSE THE WRITING IS ALSO DAMAGED. IT¿S NOT A MOULDING DEFECT. THE PLUNGER AND EVERYTHING ELSE IS OK. THE DEFECT WAS NOTICED WHEN DRAWING UP."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE BARREL WAS NOTICED TO BE DAMAGED/"CRUSHED" WHILE DRAWING UP LIQUID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BARREL OF THE SYRINGE IS DAMAGED, IT LOOKS LIKE IT HAS BEEN CRUSHED AFTER THE PAD PRINTING BECAUSE THE WRITING IS ALSO DAMAGED. IT¿S NOT A MOULDING DEFECT. THE PLUNGER AND EVERYTHING ELSE IS OK. THE DEFECT WAS NOTICED WHEN DRAWING UP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382532 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2012062

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown