BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 17139708 · Received June 15, 2023

    Report

    Report Number
    1911916-2023-00400
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 24, 2023
    Report Date
    June 23, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 21-JUN-2023 . H6: INVESTIGATION SUMMARY IT WAS REPORTED THERE WAS VISIBLE SILICONE OIL. TO AID IN THE INVESTIGATION, TEN SAMPLES BULK PACKAGED IN THREE PLASTIC BAGS WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH 10X MAGNIFICATION. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301035, LOT 2040685. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED F EMBEDDED DEGRADED RESIN.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT DURING INSPECTION 40 OF THE BD LUER-LOK SYRINGES HAD INK IN THE FLUID PATHEWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: ACCORDING TO PROCEDURE, WE SUBMIT THE ABNORMALITIES FOUND AT THE END OF THE BATCH. ALL ABNORMALITIES WERE FOUND BEFORE USE AND THUS NO PATIENTS ARE INVOLVED. INK ISSUES: 40.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INSPECTION 40 OF THE BD LUER-LOK SYRINGES HAD INK IN THE FLUID PATHEWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: ACCORDING TO PROCEDURE, WE SUBMIT THE ABNORMALITIES FOUND AT THE END OF THE BATCH. ALL ABNORMALITIES WERE FOUND BEFORE USE AND THUS NO PATIENTS ARE INVOLVED. INK ISSUES: 40.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047538 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2040685

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown