BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 13114613 · Received December 29, 2021

    Report

    Report Number
    1911916-2021-01304
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Date of Event
    December 2, 2021
    Report Date
    January 6, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 EVALUATION: YES. D10: RETURNED TO MANUFACTURER ON: 2021-12-14. H6: INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS A WHITE POWDER IN THE SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING BLISTER AND ONE PHOTO WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THERE ARE PLASTIC PARTICLES AT THE BOTTOM OF THE SYRINGE, THE INNER WALL OF THE SYRINGE BARREL HAS SOME MARKS AND THE RETAINING RING IS DAMAGED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PHOTO SHOWS A SYRINGE OUT OF THE PACKAGING BLISTER. THE SYRINGE HAS A WHITE FOREIGN MATTER ADHERED TO THE RUBBER STOPPER. THIS DEFECT COULD OCCUR DURING THE MOLDING PROCESS WHEN THE BARREL WAS TO BE EJECTED FROM THE MOLD AND DID NOT OCCUR THE FIRST TIME. THE PARTICLES OCCUR AFTER MORE THAN ONE ATTEMPT OF THE PART ATTEMPTING TO BE EJECTED FROM THE MOLDING TOOL AND COME FROM THE INNER WALL OF THE SYRINGE BARREL. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 1112044. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE MOLDING PROCESS WAS PERFORMED. MOLDING SETTINGS WERE CORRECT AND PARTS WERE BEING EJECTED WITH NO ISSUES. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE OUT OF THE PACKAGING BLISTER. THE SYRINGE HAS A WHITE FOREIGN MATTER ADHERED TO THE RUBBER STOPPER. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE PERFORMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 1112044. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHITE, POWDERY FOREIGN MATTER WAS FOUND IN THE BD LUER-LOK¿ TIP SYRINGE. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: "BEFORE USE, FOUND WHITE POWDER IN SYRINGE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHITE, POWDERY FOREIGN MATTER WAS FOUND IN THE BD LUER-LOK¿ TIP SYRINGE. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: "BEFORE USE, FOUND WHITE POWDER IN SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009369 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 1112044 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown