BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE ONLY

    MDR report key: 16427307 · Received February 23, 2023

    Report

    Report Number
    1911916-2023-00088
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    January 24, 2023
    Report Date
    February 1, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THE SYRINGE HAD A GROWTH IN THE BOTTOM. TO AID IN THE INVESTIGATION, FOURTEEN SAMPLES AND THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THIRTEEN OF THE SAMPLES CAME IN SEALED PACKAGING BLISTERS AND ONE SAMPLE WAS RECEIVED IN AN OPENED PACKAGING BLISTER. A VISUAL INSPECTION WAS PERFORMED. NO DEFECTS OR IMPERFECTIONS WERE OBSERVED IN THE THIRTEEN SAMPLES IN SEALED PACKAGING BLISTERS. THE ADDITIONAL SAMPLE HAS VISIBLE LUBRICANT ON THE RUBBER STOPPER, WHICH IS AN ACCEPTABLE IMPERFECTION. THE LUBRICANT IS MEDICAL GRADE AND IS ADDED TO THE RUBBER STOPPER AND INNER WALL OF THE SYRINGE BARREL AS A PART OF THE MANUFACTURING PROCESS. IT COULD BE POSSIBLE THAT OUR CUSTOMER GOT CONFUSED WITH THE VISIBLE LUBRICANT THAT IS APPLIED TO THE COMPONENTS OF THE SYRINGE. THE THREE PHOTOS PROVIDED SHOW ONE OF THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT 2243878. 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 RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ TIP SYRINGE ONLY FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE: 30ML BD SYRINGE HAD GROWTH IN THE BOTTOM OF SYRINGE. GROWTH WAS IDENTIFIED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514639 BD LUER-LOK¿ TIP SYRINGE ONLY PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302832 2243878 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown