BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 11159249 · Received January 13, 2021

    Report

    Report Number
    1911916-2021-00021
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 15, 2020
    Report Date
    February 26, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 170282. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, TWO PHYSICAL SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES CAME IN SEALED PACKAGING BLISTERS AND A VISUAL INSPECTION WAS PERFORMED. BOTH SAMPLES HAVE THE BARREL WITH EMBEDDED DEGRADED RESIN AND NO OTHER DEFECT OR IMPERFECTION WAS OBSERVED. THE CAUSE FOR THIS DEFECT COULD HAVE RESULTED DURING THE SYRINGE MOLDING PROCESS. WHEN THE EMBEDDED DEGRADED RESIN CAN BUILD UP IN THE HOT RUNNER SYSTEM AND BECOME LOOSE AND BREAK OFF, BECOMING MOLDED INTO THE COMPONENTS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN 2 BD LUER-LOK¿ TIP SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOREIGN MATERIAL IN SYRINGE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 170282. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, TWO PHYSICAL SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES CAME IN SEALED PACKAGING BLISTERS AND A VISUAL INSPECTION WAS PERFORMED. BOTH SAMPLES HAVE THE BARREL WITH EMBEDDED DEGRADED RESIN AND NO OTHER DEFECT OR IMPERFECTION WAS OBSERVED. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. ROOT CAUSE DESCRIPTION: THE CAUSE FOR THIS DEFECT COULD HAVE RESULTED DURING THE SYRINGE MOLDING PROCESS. WHEN THE EMBEDDED DEGRADED RESIN CAN BUILD UP IN THE HOT RUNNER SYSTEM AND BECOME LOOSE AND BREAK OFF, BECOMING MOLDED INTO THE COMPONENTS. RATIONALE: FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN 2 BD LUER-LOK¿ TIP SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOREIGN MATERIAL IN SYRINGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55914 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 0170282 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1