BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 16GA 1-1/2IN

    MDR report key: 12337768 · Received August 18, 2021

    Report

    Report Number
    3002682307-2021-00415
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 19, 2021
    Report Date
    November 9, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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: 8/18/2021. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 180701. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. THE STERILIZATION PARAMETERS WERE IN COMPLIANCE WITH THE VALIDATED PROCESS AND BIOLOGICAL INDICATORS FOR THE STERILITY TEST WERE SATISFACTORY; PASSING THE 40 EXTERNAL PROCESS CHALLENGE DEVICES (PCDS) WHICH WERE USED TO MONITOR THE LOAD. EACH PCD CONTAINED A BIOLOGICAL INDICATOR, WHICH IS A PAPER STRIP IMPREGNATED WITH BACILLUS ATROPHAEUS (106 SPORES PER STRIP) AND ALL OF THEM WERE KILLED DURING THE STERILIZATION PROCESS. IN ADDITION, A BACTERIAL ENDOTOXIN TEST WAS PERFORMED IN THE BATCH WHICH WAS ALSO FOUND IN COMPLIANCE WITH SPECIFICATIONS. MOREOVER, A BIOBURDEN TEST WAS CONDUCTED FOR MICROLANCE NEEDLES AND THE RESULTS OBTAINED DURING THE QUARTER WHEN THE INVOLVED BATCH WAS MANUFACTURED WERE SATISFACTORY WITH NO PRESENCE OF FUNGUS OR BACTERIA BEFORE THE STERILIZATION PROCESS. ADDITIONALLY, AN ENVIRONMENTAL MONITORING PROGRAM WAS DEFINED IN THE CLEANROOM WHERE THE MICROLANCE NEEDLES ARE MANUFACTURED: CLEANROOM II. EVERY MONTH A VIABLE PARTICLE TEST, A NONVIABLE PARTICLES TEST, AND A MICROBIOLOGICAL CONTROL OF SURFACE TEST ARE CONDUCTED IN THE CLEANROOM. THE ENVIRONMENTAL CONTROL RESULTS WERE BELOW THE ALERT AND ACTION LIMITS, DEMONSTRATING THAT THE ENVIRONMENT OF THE CLEANROOM WAS UNDER CONTROL. THIS IS THE FIRST COMPLAINT RECEIVED FOR MATERIAL 300637 AND LOT 180701. A HISTORICAL REVIEW OF COMPLAINT RECORDS DATING BACK FIVE YEARS WAS COMPLETED AND THIS IS THE FIRST COMPLAINT RECEIVED FOR STERILITY QUESTIONED ON MATERIAL 300637. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWENTY SAMPLES HAVE BEEN RETURNED BY THE CUSTOMER. HOWEVER, CONSIDERING WE DO NOT HAVE CONFIRMATION OF THE CONDITIONS IN WHICH THE PRODUCT HAS BEEN STORED, THE MANUFACTURING PLANT CANNOT USE THE SAMPLES PROVIDED TO PERFORM ANY STERILITY TESTING. RETAINED SAMPLES WERE OBTAINED FOR FURTHER ANALYSIS. THE RETAINED SAMPLES WERE SUBJECTED TO STERILITY TESTING AND ALL RESULTS WERE FOUND TO BE SATISFACTORY. BASED ON THE INVESTIGATION RESULTS, NO ISSUES REGARDING THE STERILIZATION PROCESS FOR THIS PARTICULAR LOT NUMBER HAVE BEEN FOUND. WE CONCLUDE THAT ALL MANUFACTURING AND STERILIZATION RESULTS HAVE BEEN FOUND CORRECT AND THEREFORE, WE ARE NOT ABLE TO ATTRIBUTE THE REPORTED EXPERIENCE WITH THE PRODUCT WITH ANY FAILURE OR ISSUE DURING THE MANUFACTURING PROCESS. THE ORIGIN OF THIS ISSUE MAY BE RELATED TO THE TRANSPORTATION, HANDLING, OR STORAGE CONDITIONS OF THE PRODUCT POST MANUFACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 100 NEEDLES 16GA 1-1/2IN FAILED A STERILITY TEST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRODUCT FAILED STERILITY TEST IN THIRD PARTY SITE".

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT 100 NEEDLES 16GA 1-1/2IN FAILED A STERILITY TEST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRODUCT FAILED STERILITY TEST IN THIRD PARTY SITE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233609 NEEDLE 16GA 1-1/2IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 180701

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown