BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12682187 · Received October 22, 2021

    Report

    Report Number
    3002682307-2021-00569
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    September 24, 2021
    Report Date
    December 3, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 11/22/2021. H.6. INVESTIGATION: 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, EIGHT AFFECTED SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, THE BLISTER PACKAGES WERE OBSERVED OPEN ON ONE SIDE DUE TO A MISALIGNED CUT. IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED IN THE PRIMARY PACKAGING MACHINE WITHIN THE CUTTING SYSTEM. A PUNCTUAL FAILURE OCCURRED IN THE CUTTING SYSTEM AND AN INCORRECT CUT BETWEEN THE CAVITIES WAS PERFORMED. THE DIFFERENT CAVITIES PRESENT A SEALED AREA OF THE BLISTER PACKAGE. THE CUTTING OF THE BLISTER WAS MISALIGNED AND THE SEALED AREA WAS NOT MAINTAINED. THE CUTTING SYSTEM IS CHECKED PERIODICALLY, BUT IN THIS CASE, WE BELIEVE THAT THE BLISTER STRIP WAS MANUFACTURED AND NOT REJECTED BEFORE THE PERIODIC CHECK OF THE SYSTEM. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA HAD PACKAGING THAT WAS NOT SEALED PROPERLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE PACKAGING OF THE SYRINGE IS NOT SEALED."

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). 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 · 1

    IT WAS REPORTED SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA HAD PACKAGING THAT WAS NOT SEALED PROPERLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THE PACKAGING OF THE SYRINGE IS NOT SEALED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577083 SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA PISTON SYRINGE FMI BECTON DICKINSON, S.A. 2010170

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown