BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUERLOK SYRINGE

    MDR report key: 16908327 · Received May 10, 2023

    Report

    Report Number
    1911916-2023-00291
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    April 18, 2023
    Report Date
    June 2, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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: 30-MAY-2023. H6: INVESTIGATION SUMMARY: IT WAS REPORTED THERE WERE HOLES AND DIRT IN THE PACKAGING. TO AID IN THE INVESTIGATION, FOUR SAMPLES IN SEALED PACKAGING BLISTERS AND FIVE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THREE OF THE SAMPLES RECEIVED ARE LOT 1299289, AND ONE SAMPLE IS FROM LOT 1103473. A VISUAL INSPECTION WAS PERFORMED. FIRST, WITH 10X MAGNIFICATION AND THE WITH A 30X MICROSCOPE. FROM LOT 1299289, TWO SAMPLES HAVE EMBEDDED DEGRADED RESIN; ONE HAS IT AT THE LUER TIP AND THE OTHER AT THE SYRINGE BARREL FLANGE AREA. THE THIRD SAMPLE HAS A HAND DRAWN CIRCLE ON THE TOP WEB WHERE THERE IS A WRINKLE. THE PACKAGING WEB IS NOT DAMAGED OR PERFORATED. FROM LOT 1103473, THE SAMPLE HAS A HAND DRAWN CIRCLE ON THE TOP BOTTOM WEB WHERE THERE IS A WRINKLE. THE PACKAGING BOTTOM WEB IS NOT DAMAGED OR PERFORATED. THE FIVE PHOTOS PROVIDED SHOW THE SAMPLES RECEIVED. 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 303552, LOTS 1299289 AND 1103473. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS 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 SAMPLE ANALYSIS THE SYMPTOM OF FOREIGN MATTER REPORTED BY THE CUSTOMER IS CONFIRMED, BUT THE SYMPTOM OF THE PACKAGING DAMAGED COULD NOT BE CONFIRMED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. 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 2 BD LUERLOK SYRINGE EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REASON: 2 UNITS - PRESENCE OF DIRT NEAR THE FLANGE AND NOZZLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD LUERLOK SYRINGE EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REASON: 2 UNITS - PRESENCE OF DIRT NEAR THE FLANGE AND NOZZLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199391 BD LUERLOK SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 1299289

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown