BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 7582386 · Received June 8, 2018

    Report

    Report Number
    3003152976-2018-00234
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Date of Event
    May 17, 2018
    Report Date
    July 18, 2018
    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

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. UPON VISUAL INSPECTION OF THE TWO PICTURE SAMPLES, FOREIGN MATTER WAS NOT OBSERVED WITHIN THE SYRINGES. TEN RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FOR EVALUATION. UPON INSPECTION OF THE RETAINED SAMPLES, NO FOREIGN MATTER WAS OBSERVED. A DEVICE HISTORY RECORD REVIEW DID NOT FIND ANY DEVIATIONS OR NON-CONFORMANCES DURING THE PRODUCTION OF LOT NUMBER 1802252 THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT OF FOREIGN MATTER. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. AS THE REPORTED DEFECT WAS NOT IDENTIFIED, A CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. SINCE NO FOREIGN MATTER CAN BE APPRECIATED IN THE PICTURES RECEIVED, NO FOREIGN MATTER HAS BEEN FOUND IN RETAINED SAMPLES EVALUATED AND NO INCIDENCE HAS BEEN FOUND IN DHR REVIEW, NO FORMAL CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE HAD FOREIGN MATTER (PLASTIC PARTICLE) VISIBLE INSIDE THE SYRINGE. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). 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¿ SYRINGE HAD FOREIGN MATTER (PLASTIC PARTICLE) VISIBLE INSIDE THE SYRINGE. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427193 BD PLASTIPAK¿ SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1802252

    Patients

    Seq Age Sex Outcome Treatment
    1 Other