BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LS SP120

    MDR report key: 18572579 · Received January 24, 2024

    Report

    Report Number
    3003152976-2024-00045
    Event Type
    Malfunction
    Date Received
    January 24, 2024
    Date of Event
    January 2, 2024
    Report Date
    February 6, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903031726
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 9538928: INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON INSPECTION OF THE PRODUCT, IT WAS OBSERVED THAT THE SYRINGE PERFORATED THE SEALING CORD, CAUSING THE BLISTER PACK TO OPEN, VERIFYING THE REPORTED INCIDENT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2203146, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS WAS DUE TO A FAILURE IN THE SYNCHRONIZATION OF THE PACKAGING MACHINE AND THE ADVANCEMENT OF THE PRODUCT WITHIN THE LINE WHICH CAUSED THE SYRINGE TO MOVE AND CREATED THE OPENING OBSERVED WITHIN THE SEAL. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THERE WAS A GAP IN THE SEAL OF THE SEALED PACKAGING BAG, WHICH EXPOSED THE NEEDLE. PLEASE INVESTIGATE IF SOME SORT OF ISSUE COULD BE OCCUR IN YOUR PROCESS.

    Description of Event or Problem · 0

    THERE WAS A GAP IN THE SEAL OF THE SEALED PACKAGING BAG, WHICH EXPOSED THE NEEDLE. PLEASE INVESTIGATE IF SOME SORT OF ISSUE COULD BE OCCUR IN YOUR PROCESS. PER CUSTOMER RESPONSE RECEIVED 25JAN2025: THE BLISTER SEAM IS FULLY VISIBLE AND HAS NO DISCONTINUITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211383 SYRINGE 1ML LS SP120 SYRINGE, PISTON FMF BECTON DICKINSON 2203146 00382903031726

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown