BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA

    MDR report key: 11069372 · Received December 23, 2020

    Report

    Report Number
    2243072-2020-02153
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    August 10, 2020
    Report Date
    March 16, 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

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1901185. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION. THE RETAINED SAMPLES WERE INSPECTED AND NO DEFECTS WERE IDENTIFIED. BASED ON THE PROVIDED FEEDBACK WE HAVE CONCLUDED THAT THE REPORTED INCIDENT COULD HAVE RESULTED DUE TO A DAMAGED PLUNGER LIP COMPONENT. THIS TYPE OF DAMAGE MAY OCCUR DURING THE HANDLING OF THE PRODUCT THROUGHOUT THE MANUFACTURING AND ASSEMBLY PROCESSES; HOWEVER, WITHOUT THE AFFECTED SAMPLE, THIS CAUSE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA WAS DAMAGED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE NURSE PERFORMED THE DOSING OPERATION TO EXTRACT THE NS, THE WATER LEAKED, AND THE INSPECTION FOUND THAT THERE WAS A DEFECT (A GAP) INSIDE THE SYRINGE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA WAS DAMAGED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE NURSE PERFORMED THE DOSING OPERATION TO EXTRACT THE NS, THE WATER LEAKED, AND THE INSPECTION FOUND THAT THERE WAS A DEFECT (A GAP) INSIDE THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531164 SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1901185

    Patients

    Seq Age Sex Outcome Treatment
    1