BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML CT

    MDR report key: 11558556 · Received March 23, 2021

    Report

    Report Number
    3003152976-2021-00161
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Date of Event
    February 25, 2021
    Report Date
    May 24, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 4/13/2021. H.6. INVESTIGATION: MULTIPLE PHOTOS AND BLISTERS OF PRODUCT 300867, LOT 2019997 WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, YELLOW STAINS CAN BE OBSERVED ON THE BLISTER PACKS. IT WAS NOTED THE STAINING ON IS ON THE OUTSIDE THE SEALING CORD INDICATING THE INSIDE OF THE BLISTER IS NOT IMPACTED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2010007, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. STERILIZATION RECORDS WERE REVIEWED AND VERIFY THE CYCLE WAS COMPLETED ACCORDING TO PROCEDURE, NO ISSUES OCCURRED DURING THIS PROCESS. 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 COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT WAS A RESULT OF WATER CONDENSATION PRESENT IN THE SEALING DIE DURING THE PACKAGING PROCESS WHICH RESULTED IN THE STAINING THAT WAS OBSERVED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BOXES OF SYRINGES 50ML CT HAD RUSTY, BROWN, DAMP SPOTS ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "HAS BROWN ¿RUST¿ DAMP SPOTS DESPITE THE OUTER BOX HAS NO VISIBLE MOISTURE OR OTHER DAMAGE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THAT 2 BOXES OF SYRINGES 50ML CT HAD RUSTY, BROWN, DAMP SPOTS ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "HAS BROWN ¿RUST¿ DAMP SPOTS DESPITE THE OUTER BOX HAS NO VISIBLE MOISTURE OR OTHER DAMAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450183 SYRINGE 50ML CT PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2010007

    Patients

    Seq Age Sex Outcome Treatment
    1