BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 16896580 · Received May 9, 2023

    Report

    Report Number
    3002682307-2023-00108
    Event Type
    Malfunction
    Date Received
    May 9, 2023
    Date of Event
    April 17, 2023
    Report Date
    July 12, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 19-JUN-2023. H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 220924. 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, THE AFFECTED SAMPLE WAS RETURNED FOR EVALUATION BY OUR INVESTIGATIVE TEAM. THE NEEDLE SAMPLE ARRIVED ASSEMBLED WITH A SYRINGE. AFTER EXAMINATION, THE PRESENCE OF EPOXY (THE ADHESIVE USED TO JOIN THE CANNULA TO THE HUB) WAS OBSERVED ON THE CANNULA SURFACE. IN ADDITION TO THE AFFECTED SAMPLE, NINE (9) SHELF CARTONS WITH ONE HUNDRED (100) NEEDLES EACH AND A SHELF CARTON WITH TWELVE (12) NEEDLES WERE PROVIDED. TWENTY (20) SAMPLES WERE RANDOMLY SELECTED FOR A THOROUGH ANALYSIS. THE SAMPLES WERE VISUALLY EXAMINED; HOWEVER, NO SIGNS OF DEFECT WERE IDENTIFIED. THE EPOXY ON THE CANNULA SURFACE RESULTED DURING THE ASSEMBLY PROCESS DUE TO A TEMPORARY MALFUNCTION IN THE EPOXY DOSAGE MACHINE. A HIGHER AMOUNT OF EPOXY WAS ADDED AND THEN FELL ONTO THE AFFECTED CANNULA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: WHEN USING THE ABOVE NEEDLE, THERE APPEARED TO BE A THICKENING AT THE INSERTION TIP. IT INVOLVED A "GLUE" BALL ON THE NEEDLE, CONSEQUENTLY DIFFICULT INSERTION IN THE PATIENT WITH BRUISING TO THE EYEBALL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: WHEN USING THE ABOVE NEEDLE, THERE APPEARED TO BE A THICKENING AT THE INSERTION TIP. IT INVOLVED A "GLUE" BALL ON THE NEEDLE, CONSEQUENTLY DIFFICULT INSERTION IN THE PATIENT WITH BRUISING TO THE EYEBALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955315 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 220924

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown