BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML LL S/C 48

    MDR report key: 12996501 · Received December 14, 2021

    Report

    Report Number
    1911916-2021-01257
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 15, 2021
    Report Date
    November 24, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT TINY FRAGMENTS OF RUBBER WERE BREAKING OFF IN THE SYRINGE. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A HUMAN HAND HOLDING A SYRINGE WITH A CLEAR SOLUTION AND A NEEDLE ASSEMBLY CONNECTED TO IT. THE PLUNGER ROD-RUBBER STOPPER HAS BEEN PULLED ALL THE WAY AND, FROM THE PHOTO, IT APPEARS THERE IS ONE BLACK SPOT IN THE CLEAR SOLUTION AT THE 9ML MARK. NO OTHER DEFECTS OR IMPERFECTIONS ARE OBSERVED. THE ROOT CAUSE IS NOT KNOWN, BUT COULD BE CAUSED BY WHAT DRUG WAS FILLED IN THE SYRINGE, HOW LONG THE DRUG HAS BEEN STORED IN THE SYRINGE OR THE STORAGE CONDITIONS WHILE THE SYRINGE IS FILLED WITH THE DRUG. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT NUMBER 1223044. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. A TREND ANALYSIS OF THIS PRODUCT WAS DONE FOR THE LAST 3 YEARS AND THIS IS THE FIRST COMPLAINT FOR THIS SYMPTOM FROM ANY CUSTOMER. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SYRINGE 20ML LL S/C 48, THE DEVICE EXPERIENCED FOREIGN MATTER IN THE FLUID PATH COMPONENT. THIS EVENT OCCURRED 8 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: TINY FRAGMENTS OF RUBBER REPORTED TO BE BREAKING OFF AND RESULTING IN CUSTOMER HAVING TO WASTE PRODUCT. 8 SYRINGES HAVE BEEN REPORTED. WE HAVE RECEIVED THE COMPLAINT ATTACHED FOR 8 EACH. TINY FRAGMENTS OF RUBBER REPORTED TO BE BREAKING OFF AND RESULTING IN CUSTOMER HAVING TO WASTE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899797 BD SYRINGE 20ML LL S/C 48 PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302830 1223044 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown