BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II¿ SYRINGE W/NEEDLE

    MDR report key: 7378279 · Received March 28, 2018

    Report

    Report Number
    3002682307-2018-00093
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    February 26, 2018
    Report Date
    May 7, 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD WAS NOT PROVIDED A PHOTO OR SAMPLE TO INVESTIGATE FOR THIS RECORD. AS A RESULT, BD CANNOT VERIFY THE REPORTED ISSUE. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BHR REVIEW WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE (B)(4)(APRIL 25 - 26TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, (B)(4), IN LOT #7100071 (APRIL 18 - 24TH, 2017) AND IN LOT #7112279 (APRIL 24TH - MAY 5TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARRELS LOTS #7100034, #7083118, #7089482, AND #7114311 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7100039, #7089483, #7083122, AND #7114311 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS: BASED ON OUR EXPERIENCE AND THE KIND OF CRACK ON THE SYRINGE, WE THINK THAT THE ORIGIN OF THE PROBLEM IS CAUSED DUE TO A HARD CONDITION OF HANDLING OR TRANSPORTATION. WHEN A PACKAGE OF SYRINGES IS HARDLY HIT DUE TO A STRONG HANDLING, THE FINGER GRIPS OF SOME SYRINGES CAN DAMAGE THE WALL OF THE OPPOSITE BARREL, PRODUCING SOME CRACK. THE PACKAGING MATERIAL HAS BEEN TESTED TO RESIST NORMAL CONDITIONS OF TRANSPORTATION, AND THE PRODUCT IS CONTINUOUSLY INSPECTED IN THE PROCESS. WE MUST ALSO TAKE INTO ACCOUNT THAT PLASTIC MATERIAL IS GETTING BRITTLE WITH LOW TEMPERATURES. HOWEVER, THE BARREL WILL ONLY CRACK IF WE APPLY AN EXCESSIVE FORCE ON IT. CONFIRMATION NO SAMPLE RETURNED FOR EVALUATION. NO ISSUE FOUND IN THE BATCH HISTORY RECORD REVIEW. WE COULD NOT CONFIRM THE REPORTED ISSUE. CAPA DETERMINATION BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT # 17O4514 WAS NOT FOUND TO BE A VALID LOT NUMBER, FOR THE CATALOG NUMBER REPORTED. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PULLING THE PLUNGER BACK OF A BD DISCARDIT II¿ SYRINGE W/NEEDLE, THE SYRINGE ¿IS BREAKING¿. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219655 BD DISCARDIT II¿ SYRINGE W/NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other