BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ SYRINGE

    MDR report key: 15313150 · Received August 29, 2022

    Report

    Report Number
    3002682307-2022-00222
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    August 2, 2022
    Report Date
    September 19, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    K113241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 307731 AND LOT NUMBER 2202192. 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, TWO PICTURE SAMPLES WERE RETURNED. THROUGH EVALUATION OF THE PICTURES, THE TIP OF THE SYRINGE WAS OBSERVED BROKEN. AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. THE MATERIAL USED TO MANUFACTURE THE EMERALD SYRINGES HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. THE ASSEMBLY MACHINES HAVE AN IN-LINE DETECTION SYSTEM THAT INSPECTS ALL PRODUCT AND AUTOMATICALLY REJECTS ANY DAMAGES IDENTIFIED. BASED ON THESE PREVENTIVE MEASURES, WE BELIEVE IT IS POSSIBLE THAT THE REPORTED INCIDENT RESULTED FROM A BLOCKAGE DURING THE BARREL FEEDING PROCESS. AFTER THAT, THE DAMAGED TIP OF THE SYRINGE WENT UNDETECTED DURING ASSEMBLY AND RESULTED IN BREAKAGE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD EMERALD¿ SYRINGE THEY BREAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CATALAN TO ENGLISH: WE ARE HAVING PROBLEMS WITH SYRINGE BARRELS BECAUSE THEY BREAK ESPECIALLY WITH THE ANTI-REFLUX VALVES AS YOU CAN SEE IN THE PICTURES. RUPTURES LIKE THIS ARE A SERIOUS PROBLEM WITH VIAS AS THEY CAN INDUCE CATHETER-ASSOCIATED BACTERAEMIA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD EMERALD¿ SYRINGE THEY BREAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CATALAN TO ENGLISH: WE ARE HAVING PROBLEMS WITH SYRINGE BARRELS BECAUSE THEY BREAK ESPECIALLY WITH THE ANTI-REFLUX VALVES AS YOU CAN SEE IN THE PICTURES. RUPTURES LIKE THIS ARE A SERIOUS PROBLEM WITH VIAS AS THEY CAN INDUCE CATHETER-ASSOCIATED BACTERAEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2454692 BD EMERALD¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2202192

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown