BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE PAK

    MDR report key: 10103460 · Received May 29, 2020

    Report

    Report Number
    1911916-2020-00508
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    April 24, 2020
    Report Date
    May 20, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096801
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: FOUR PHOTOS WERE PROVIDED FOR EVALUATION. ALL SAMPLES WERE VISUALLY INSPECTED. TWO PHOTOS HAVE AN AREA CIRCLED WITH PERMANENT MARKER WHERE THE EMBEDDED FOREIGN MATTER WAS OBSERVED. THE EMBEDDED FOREIGN MATTER WAS IDENTIFIED AS BURNT PLASTIC. BASED ON THE PHOTOS PROVIDED THEY ARE OF A SIZE THAT IS ACCEPTABLE. LEVEL 2 OR SMALLER. EMBEDDED BURNT PLASTIC CAN OCCUR AT THE STARTUP OF AN INJECTION MOLD/PRESS OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. DEGRADED RESIN INHERENTLY BUILDS UP IN THE BARREL AND HOT-RUNNER SYSTEM OF THE TOOLING MOLD AND PRESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. ANOTHER PHOTO SHOWS WHAT APPEARS TO BE A SMALL PIECE OF PLASTIC-POLYPROPYLENE ADHERED TO THE RUBBER STOPPER, IT CAN BE UP TO 1.2 MM. BASED ON THE PHOTO PROVIDED, IT IS OF A SIZE THAT IS ACCEPTABLE. THE FOURTH PHOTO SHOWS WHAT APPEARS TO BE SMALL AIR BUBBLE IN THE BARREL WALL, BASED ON THE SIZE OF THE AIR BUBBLE IN THE PHOTO PROVIDED IT IS ACCEPTABLE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 2ND COMPLAINT FOR LOT # 9242239 FOR THIS TYPE OF DEFECT OR SYMPTOM. PREVIOUS COMPLAINT (B)(4). THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THESE BATCH #S. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE PHOTOS THE IMPERFECTIONS ARE ACCEPTABLE. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 49 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE PAKS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309680 BATCH NO: 9242239. IT WAS REPORTED THAT DURING INSPECTION SYRINGES HAD EMBEDDED MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567324 BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE PAK PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309680 9242239 30382903096801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other