BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE 10 ML

    MDR report key: 7635362 · Received June 25, 2018

    Report

    Report Number
    9614033-2018-00035
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    April 18, 2018
    Report Date
    August 23, 2018
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, HOWEVER THIS FAILURE MODE OF LEAKAGE IS BEING INVESTIGATED UNDER A CORRECTIVE AND PREVENTIVE ACTION, THEREFORE THE DEFECTS ARE CONFIRMED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THE DIAL WHERE THE ASSEMBLY IS MADE MAY BE CAUSING DAMAGE TO THE SIRINGE ( SEE IMAGE 1), HOWEVER THERE IS A SENSOR TO EJECT THE SYRINGES WHEN THEY ARE NOT WELL ASSEMBLED AND THIS SENSOR IS A SECTION BEHIND WHERE THE JAM IS BEING PRESENTED. THAT ITS FUNCTIONALITY HAS NOT BEEN ALL EFFECTIVE. IT IS IMPORTANT TO MENTION THAT THE DEFECT CAN OCCUR WITHIN THE PROCESS, WHICH IS WHY IT IS CONSIDERED WITH AN ACCEPTABLE QUALITY LEVEL OF 0.25%, WHICH MEANS THAT HAVING A LOT SIZE OF 436,800 PIECES, THERE COULD BE 5 PIECES WITH THIS DEFECT THE MODE OF FAILURE OF THE INADEQUATE FUNCTIONING OF THE LEAK TEST BOLT IN THE ASSEMBLY EQUIPMENT WAS ALSO IDENTIFIED, THIS IS BECAUSE SINCE IT IS MOVING WITH A SHORT SPACE WHICH CAUSES IT NOT TO BE REPRESENTATIVE IN ORDER TO DETECT THE DEFECT. REGARDING THE FAILURE MODE OF THE QUALIFICATION OF THE PERSONNEL (MSA), NOWADAYS THE OPERATIVE PERSONNEL IS TRAINED IN THE WORK INSTRUCTIONS AS WELL AS IN THE FREQUENCIES WHERE DEFECTIVES ARE MENTIONED THAT COULD BE PRESENTED, HOWEVER, THERE IS NO QUALIFICATION ( MSA) THAT ENSURES THAT THE OPERATORS IDENTIFIES AND KNOWS THE DEFECTS. THE ASSEMBLY EQUIPMENT HAS A TOOLING THAT DURING THE PROCESS RUNS THE LEAK TEST TO EACH PIECE MANUFACTURED SO IT WAS NOT CONSIDERED NECESSARY TO PERFORM LEAK TEST AS PART OF THE FINAL INSPECTION. IT IS IMPORTANT TO MENTIONING THAT GIVEN THE EVENT OF THE LEAKAGE, (B)(4) WAS GENERATED TO FOLLOW UP ON ALL THE FAILURE MODES IDENTIFIED AND THEIR RESPECTIVE ACTION PLAN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PLASTIPAK SYRINGE 10 ML WAS LEAKING. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7137557, MEDICAL DEVICE EXPIRATION DATE: 2022-04-30, DEVICE MANUFACTURE DATE: 2017-07-04. MEDICAL DEVICE LOT #: 7170830, MEDICAL DEVICE EXPIRATION DATE: 2022-08-06, DEVICE MANUFACTURE DATE: 2017-08-15. MEDICAL DEVICE LOT #: 8016550, MEDICAL DEVICE EXPIRATION DATE: 2022-12-31, DEVICE MANUFACTURE DATE: 2018-02-27. MEDICAL DEVICE LOT #: 8016527, MEDICAL DEVICE EXPIRATION DATE: 2022-12-31, DEVICE MANUFACTURE DATE: 2018-03-20. 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 A BD PLASTIPAK¿ SYRINGE 10 ML WAS LEAKING. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475324 BD PLASTIPAK¿ SYRINGE 10 ML SYRINGE FMF BECTON DICKINSON DE MEXICO SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other