BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 15477702 · Received September 24, 2022

    Report

    Report Number
    1911916-2022-00523
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Date of Event
    July 14, 2022
    Report Date
    October 6, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903028320
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    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: 03-OCT-2022. H.6. INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS FOREIGN MATTER IN THE SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, FIRST WITH THE NAKED EYE AND THEN WITH A 30X MICROSCOPE. THERE IS A FOREIGN MATTER AT THE PLUNGER ROD THAT IS 1/4" LONG AND 1/8" WIDE. IT IS A PIECE OF A FILTER DURING THE PACKAGING LINE ASSEMBLY PROCESS. THIS DEFECT COULD OCCUR IF, AFTER A REPAIR OR PREVENTATIVE MAINTENANCE, THE LOOSE PARTICLE ENDED UP IN THE PACKAGING BLISTER OR ADHERED TO THE PLUNGER ROD. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE THREE PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT NUMBER 2070242. 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 ASSEMBLY AND PACKAGING PROCESSES WERE PERFORMED. THE AREAS WERE CLEAN WITH NO RESIDUES OF ANY PARTICLES OR ANY KIND OF FOREIGN MATTER. THE SAMPLE WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BUG WAS FOUND IN THE SEALED BD LUER-LOK¿ TIP SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE FOUND A BUG IN AN SEALED 30ML SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BUG WAS FOUND IN THE SEALED BD LUER-LOK¿ TIP SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE FOUND A BUG IN AN SEALED 30ML SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467855 BD LUER-LOK¿ TIP SYRINGE PISTONS SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2070242 00382903028320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown