BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SOLOMED¿ SYRINGE

    MDR report key: 16522314 · Received March 10, 2023

    Report

    Report Number
    3002682307-2023-00049
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    February 13, 2023
    Report Date
    May 15, 2023
    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

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302772 AND LOT NUMBER 2110403. 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 (20) RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR REVIEW. HOWEVER, THE RETAINED SAMPLES DID NOT DISPLAY ANY SIGNS OF DEFECT. BASED ON THE INVESTIGATION RESULTS, WE WERE UNABLE TO IDENTIFY A MANUFACTURING RELATED CAUSE FOR THIS REPORTED INCIDENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD SOLOMED¿ SYRINGES' HUBS WERE SKEWED/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE DEALER REPORTED THAT... THE PACKAGING OF THE SEALED SYRINGE WAS FOUND TO BE SKEWED AT THE JUNCTION BETWEEN THE METAL PART OF THE NEEDLE AND THE PLASTIC."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD SOLOMED¿ SYRINGES' HUBS WERE SKEWED/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE DEALER REPORTED THAT THE PACKAGING OF THE SEALED SYRINGE WAS FOUND TO BE SKEWED AT THE JUNCTION BETWEEN THE METAL PART OF THE NEEDLE AND THE PLASTIC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182097 BD SOLOMED¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110403

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown