BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 15520667 · Received September 30, 2022

    Report

    Report Number
    1911916-2022-00547
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    August 8, 2022
    Report Date
    October 10, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903028306
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL: YES D.9. RETURNED TO MANUFACTURER ON: 28-SEP-2022 H.6. INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS RESIDUE ON THE INSIDE OF THE SYRINGE. TO AID IN THE INVESTIGATION, TWO SAMPLES AND FIVE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE SAMPLE CAME IN A SEALED PACKAGING BLISTER AND THE OTHER SAMPLE CAME IN AN OPENED PACKAGING BLISTER. A VISUAL INSPECTION WAS PERFORMED AND BOTH SAMPLES HAVE EMBEDDED DEGRADED RESIN IN THE SYRINGE BARREL. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. 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. THE FIVE PHOTOS PROVIDED SHOW THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT NUMBER 2152001. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THE FREQUENCY OF INSPECTIONS WERE INCREASED TO MITIGATE THE ESCAPES OF THE EMBEDDED DEGRADED RESIN DEFECTS. 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. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    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 FOREIGN RESIDUE WAS FOUND INSIDE THE BD LUER-LOK¿ TIP SYRINGE WHEN REMOVING IT FROM THE PACKAGING. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SYRINGE CONTAINED RESIDUE ON THE INSIDE OF THE SYRINGE WHEN REMOVED FROM THE STERILE PACKAGING."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN RESIDUE WAS FOUND INSIDE THE BD LUER-LOK¿ TIP SYRINGE WHEN REMOVING IT FROM THE PACKAGING. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SYRINGE CONTAINED RESIDUE ON THE INSIDE OF THE SYRINGE WHEN REMOVED FROM THE STERILE PACKAGING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2646928 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2152001 00382903028306

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown