BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLES

    MDR report key: 16482209 · Received March 3, 2023

    Report

    Report Number
    3002682307-2023-00040
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    February 6, 2023
    Report Date
    April 3, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304432 AND LOT NUMBER 220626. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO (2) PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURED LABELING, NO DEFECTS WERE FOUND, AS THE LABELING WAS THE CURRENTLY APPROVED LABEL.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 PRIOR TO USE WITH BD MICROLANCE¿ 3 NEEDLES THE MEDICAL DEVICE LABEL WAS MISSING FROM THE PACKAGE. THIS IS THE 2ND OCCURRENCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: OUR CUSTOMER INFORMED US THAT ANOTHER BATCH OF MICROLANCE DID NOT HAVE MEDICAL DEVICE (MD) LABELING ON PACKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD MICROLANCE¿ 3 NEEDLES THE MEDICAL DEVICE LABEL WAS MISSING FROM THE PACKAGE. THIS IS THE 2ND OCCURRENCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: OUR CUSTOMER INFORMED US THAT ANOTHER BATCH OF MICROLANCE DID NOT HAVE MEDICAL DEVICE (MD) LABELING ON PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913046 BD MICROLANCE¿ 3 NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 220626

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown