BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 2ML 25GA 1IN

    MDR report key: 11345782 · Received February 18, 2021

    Report

    Report Number
    3002682307-2021-00064
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    January 22, 2021
    Report Date
    May 11, 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 1901191. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED AND THEREFORE, THE REPORTED DEFECT COULD NOT BE IDENTIFIED. BASED ON THE PRODUCTS MANUFACTURED AT THIS LOCATION, THERE IS NOT A POSSIBILITY OF BLUE AND YELLOW SYRINGES. PER THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE AN INCIDENT OF MIXED PRODUCT IS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES S2 2ML 25GA 1IN EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE CUSTOMER OPENED THE PACKAGE, HE FOUND SYRINGES IN TWO COLORS (BLUE AND YELLOW), IT SHOULD BE ALL ONE COLOR.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES S2 2ML 25GA 1IN EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE CUSTOMER OPENED THE PACKAGE, HE FOUND SYRINGES IN TWO COLORS (BLUE AND YELLOW), IT SHOULD BE ALL ONE COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240727 SYRINGE S2 2ML 25GA 1IN SYRINGE FMF BECTON DICKINSON, S.A. 1901191

    Patients

    Seq Age Sex Outcome Treatment
    1