BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML SALINE FILL CHINA SP

    MDR report key: 19173844 · Received April 24, 2024

    Report

    Report Number
    1911916-2024-00281
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    March 30, 2024
    Report Date
    May 17, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903065944
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306594 AND LOT NUMBER 3090847. 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 A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THE PRODUCT IS DESIGNED TO PUSH THE PLUNGER ROD DOWN TO EXPEL THE SOLUTION. IT IS NOT FOR PULLING THE PLUNGER ROD BACK. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    AFTER USE, THE NURSE PULLS BACK WITH THE HAND AND THE PIN IS SEPARATED FROM THE SKIN PLUG.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. AFTER USE, THE NURSE PULLS BACK WITH THE HAND AND THE PIN IS SEPARATED FROM THE SKIN PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084727 SYRINGE 5ML SALINE FILL CHINA SP SYRINGE, PISTON FMF BECTON DICKINSON 3090847 30382903065944

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown