BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA

    MDR report key: 12379049 · Received August 27, 2021

    Report

    Report Number
    3002682307-2021-00444
    Event Type
    Malfunction
    Date Received
    August 27, 2021
    Date of Event
    July 29, 2021
    Report Date
    November 2, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2010170. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, A PICTURE OF THE AFFECTED SAMPLES WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, IT APPEARED THAT THE CUTTING OF THE BLISTER PACKAGES HAD BEEN MISALIGNED, CAUSING THE BLISTER TO BE OPEN ON ONE SIDE. THIS TYPE OF DEFECT RESULTED IN THE PRIMARY PACKAGING MACHINE. THE MACHINE HAS A CUTTING SYSTEM AND DUE TO A PUNCTUAL FAILURE, INCORRECT CUTS WERE MADE. THE CUTTING OF THE BLISTER PACKAGES MUST BE DONE CORRECTLY TO KEEP THE SEALED AREA OF EACH UNIT. SINCE THE BLISTER CUTTING SYSTEM WAS MISALIGNED, THE SEALED AREA WAS NOT MAINTAINED WHICH CAUSED THE BLISTER TO OPEN. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA HAD A DAMAGED PACKAGE THAT COMPROMISED STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "6 SYRINGES, CLOSE TO THE LOWER END WHEN SEALING THE EDGE, NOT SEALED."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 6 SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA HAD A DAMAGED PACKAGE THAT COMPROMISED STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "6 SYRINGES, CLOSE TO THE LOWER END WHEN SEALING THE EDGE, NOT SEALED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276595 SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2010170

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown