BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 20ML 21GA 1-1/2IN

    MDR report key: 12321614 · Received August 13, 2021

    Report

    Report Number
    3002682307-2021-00408
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    July 16, 2021
    Report Date
    July 27, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2102505. 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. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION. THE RETAINED SAMPLES WERE INSPECTED AND NO DEFECTS WERE OBSERVED. PER THE PROVIDED FEEDBACK, IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM DAMAGE TO THE PLUNGER LIP COMPONENT. THIS TYPE OF DAMAGE MAY OCCUR DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING FACILITY OR WITHIN THE PLUNGER ASSEMBLY MACHINE. BASED ON THE 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. INVESTIGATION CONCLUSION: BASED ON THE CUSTOMER FEEDBACK OF THE ISSUE, WE CONCLUDE THAT THE CAUSE OF THE PROBLEM COULD BE PRODUCED AS A CONSEQUENCE OF A DAMAGE IN THE PLUNGER LIP, THAT DAMAGE CAUSED THE REPORTED LEAK ISSUE. THIS DAMAGE COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SYRINGE S2 20ML 21GA 1-1/2IN EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCARDIT II 20ML WITH NEEDLE LEAK AND BREAK DURING USE OF ADMINISTRATION OF MRI CONTRAST MEDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215172 SYRINGE S2 20ML 21GA 1-1/2IN SYRINGE FMF BECTON DICKINSON, S.A. 2102505

    Patients

    Seq Age Sex Outcome Treatment
    1