BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 12807885 · Received November 12, 2021

    Report

    Report Number
    3002682307-2021-00610
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Date of Event
    July 27, 2021
    Report Date
    November 9, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2010124. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, A SHELF CARTON OF MATERIAL 309050, LOT NUMBER 2010124 WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THIS SHELF CARTON OF PRODUCT WAS SENT TO THE CHINESE CUSTOMER DUE TO A MIX OF PRODUCT DURING PRODUCTION. MATERIAL 309050 IS PRODUCED IN A PACKAGING LINE CLOSE TO THE PACKAGING LINE WHICH PRODUCES DISCARDIT 5ML SYRINGES FOR CHINA. THE SECONDARY PACKAGING MACHINES ARE MANAGED BY THE SAME OPERATOR. IT IS POSSIBLE THAT THE OPERATOR MISTAKENLY INTRODUCED SOME OF THE MATERIAL 309050 PRODUCT INTO THE OTHER PACKAGING LINE. IT HAS BEEN DETERMINED THAT THIS ISSUE RESULTED FROM HUMAN ERROR AND MANIPULATION OF THE PRODUCT IN THE PACKAGING STATION. BASED ON OUR STRICT PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD DISCARDIT¿ II SYRINGE, THE DEVICE EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK. THIS EVENT OCCURRED 100 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: HYPO-- SYRINGE WITHOUT NEEDLE PROBLEM PRODUCTS 100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1701607 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2010124

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown