BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ SYRINGE

    MDR report key: 16653056 · Received March 30, 2023

    Report

    Report Number
    3002682307-2023-00086
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 14, 2023
    Report Date
    June 5, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 12-APRIL-2023 . H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 307736 AND LOT NUMBER 2212153. 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 SAMPLE AND THE AFFECTED PHYSICAL SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, A NON-SEALED PORTION OF THE BLISTER PACKAGE WAS IDENTIFIED. IT HAS BEEN DETERMINED THAT THIS DEFECT RESULTED FROM A MISALIGNMENT IN THE UNITARY CUTTING SYSTEM WHICH CUTS THE BLISTER PACKAGES BY THE CAVITY LOCATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD EMERALD¿ SYRINGE WAS POORLY PACKAGED OR NOT FULLY SEALED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: SEVERAL PACKAGES WERE POORLY OR NOT EVEN FULLY SEALED ALONG ALL EDGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD EMERALD¿ SYRINGE WAS POORLY PACKAGED OR NOT FULLY SEALED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: SEVERAL PACKAGES WERE POORLY OR NOT EVEN FULLY SEALED ALONG ALL EDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580964 BD EMERALD¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2212153

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown