BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICROLANCE ¿ 3 NEEDLES

    MDR report key: 17638564 · Received August 28, 2023

    Report

    Report Number
    3002682307-2023-00259
    Event Type
    Injury
    Date Received
    August 28, 2023
    Date of Event
    August 7, 2023
    Report Date
    October 4, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. 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 HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL?: YES. D9: RETURNED TO MANUFACTURER ON: 21-SEP-2023. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 300600 AND LOT NUMBER 220823. 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, ONE (1) SHELF CARTON OF UNOPENED NEEDLE PRODUCT WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. TWENTY (20) NEEDLE SAMPLES WERE RANDOMLY SELECTED FOR THOROUGH ANALYSIS; HOWEVER, THE UNUSED SAMPLES DID NOT DISPLAY ANY SIGNS OF DEFECT. THE AFFECTED SAMPLE WAS ALSO RETURNED, WHICH CONSISTED OF A BROKEN CANNULA WITHOUT A HUB COMPONENT. THE BROKEN CANNULA WAS ALSO BENT. AT THIS TIME, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THE OBSERVED DEFECT OF BROKEN CANNULA. THE CANNULA USED IS IN ISO COMPLIANCE AND IS DESIGNED FOR THE MANUFACTURE OF MEDICAL DEVICES. IN ACCORDANCE, ANY BREAKAGE ISSUE IS VERY RARE UNLESS INAPPROPRIATE USE OF THE PRODUCT OCCURRED; FOR EXAMPLE, BENDING THE NEEDLE WHILE INJECTING. CANNULA PULL OUT TESTING IS PERFORMED FOR EVERY LOT PRODUCED PRIOR TO RELEASE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE ¿ 3 NEEDLES EXPERIENCED NEEDLE PULLED OUT OF HUB. DOG SENT TO SPECIALIST CLINIC TO HAVE NEEDLE TIP REMOVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILST INJECTION OF MEDICINE INTO AN ANIMAL (DOG WAS RESTLESS), NEEDLE TIP SNAPPED OFF THE HUB. DOG SENT TO SPECIALIST CLINIC TO HAVE NEEDLE TIP REMOVED. ANIMAL IS NOW OK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE ¿ 3 NEEDLES EXPERIENCED NEEDLE PULLED OUT OF HUB. DOG SENT TO SPECIALIST CLINIC TO HAVE NEEDLE TIP REMOVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILST INJECTION OF MEDICINE INTO AN ANIMAL (DOG WAS RESTLESS), NEEDLE TIP SNAPPED OFF THE HUB. DOG SENT TO SPECIALIST CLINIC TO HAVE NEEDLE TIP REMOVED. ANIMAL IS NOW OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2082234 BD MICROLANCE ¿ 3 NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 220823

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention