BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ NEEDLE

    MDR report key: 16325934 · Received February 8, 2023

    Report

    Report Number
    2243072-2023-00164
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    December 28, 2022
    Report Date
    April 3, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL POTENTIAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 2 BD MICROLANCE¿ NEEDLE WERE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN NEEDLES D1: MEDICAL DEVICE BRAND NAME: BD MICROLANCE¿ NEEDLE D4: UDI # (B)(4) D4: CATALOG # 304622 D4: MEDICAL DEVICE LOT #: 220213 D4: MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027 H4: DEVICE MANUFACTURE DATE: 17-FEB-2022 H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR POTENTIAL MATERIAL NUMBER 304622 AND LOT NUMBER 220213. 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. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY (20) RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR EVALUATION; HOWEVER, NO SIGNS OF DEFECT WERE FOUND IN ANY OF THE RETAINED NEEDLE SAMPLES. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 UNSPECIFIED BD NEEDLE WERE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN NEEDLES

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD MICROLANCE¿ NEEDLE WERE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2314959 BD MICROLANCE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 220213

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female