BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿3 NEEDLES 30 G

    MDR report key: 14595291 · Received June 3, 2022

    Report

    Report Number
    3002682307-2022-00154
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    May 6, 2022
    Report Date
    June 7, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 210827. MEDICAL DEVICE EXPIRATION DATE: 31JUL2026. DEVICE MANUFACTURE DATE: 20AUG2021. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBERS 210827 AND 210335. 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 RETAINED SAMPLES (TEN FROM EACH REPORTED LOT NUMBER) WERE OBTAINED FOR EVALUATION. THE RETAINED SAMPLES WERE ASSEMBLED WITH A CAVERJECT SYRINGE PROVIDED BY THE CUSTOMER IN THE PAST. THE NEEDLE SAMPLES WERE ASSEMBLED BY FOLLOWING THE CAVERJET KIT INSTRUCTIONS. NONE OF THE SAMPLES PRESENTED ANY SIGN OF DEFECT AND THE HUBS FIT PERFECTLY ON THE SYRINGE TIP. AS WE WERE UNABLE TO REPRODUCE THE REPORTED ISSUE, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICROLANCE¿3 NEEDLES 30 G THE PIECES WERE DIFFICULT TO CONNECT AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN HE WENT TO USE THE SMALL NEEDLE, HE REPORTS THAT IT BECAME LOOSE, HE PRESSED IT TO SCREW AND FIX IT AND APPLIED IT AND WHEN HE PRESSED THE PLUNGER, THE LIQUID LEAKED ALL OVER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICROLANCE¿3 NEEDLES 30 G THE PIECES WERE DIFFICULT TO CONNECT AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN HE WENT TO USE THE SMALL NEEDLE, HE REPORTS THAT IT BECAME LOOSE, HE PRESSED IT TO SCREW AND FIX IT AND APPLIED IT AND WHEN HE PRESSED THE PLUNGER, THE LIQUID LEAKED ALL OVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032595 BD MICROLANCE¿3 NEEDLES 30 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 210335

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown