BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿3 NEEDLES

    MDR report key: 16320126 · Received February 8, 2023

    Report

    Report Number
    3002682307-2023-00014
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    January 9, 2023
    Report Date
    April 5, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED DUE TO ADDITIONAL INFORMATION: IMDRF ANNEX A GRID: A1801.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 01-MARCH-2023. INVESTIGATION SUMMARY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301300 AND LOT NUMBERS 220407 AND 220536. 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, 38 UNPACKAGED NEEDLE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH MICROSCOPIC EXAMINATION, THE NEEDLES WERE FOUND TO BE PARTIALLY CLOGGED. THE MATERIAL BLOCKING THE CANNULAS APPEARED TO BE STOPPER MATERIAL. BASED ON THE PRODUCTION HISTORY RECORDS AND THE PREVENTIVE MEASURES IN PLACE, IT IS UNLIKELY THAT THE CORING EFFECT RESULTED FROM POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA. THE CANNULA COMPONENTS ARE SUBJECTED TO AN INCOMING INSPECTION INCLUDING VISUAL EXAMINATION, MEASUREMENTS, AND PENETRATION TESTS. IT IS POSSIBLE THAT THE STOPPER CONDITIONS HAD A ROLE IN THIS INCIDENT AS MATERIAL CHANGES OR STORAGE CONDITIONS RELATED TO HUMIDITY OR TEMPERATURE CAN AFFECT THE FRAGMENTATION OF THE RUBBER. IT IS ALSO POSSIBLE THAT THE HANDLING OF THE PRODUCT HAD A ROLE IN THIS INCIDENT. THE NEEDLE SHOULD PENETRATE THE VIAL STOPPER AT A NINETY-DEGREE ANGLE TO MINIMIZE THE RISK OF CATCHING THE INTERNAL WALL OF THE VIAL STOPPER. AT THIS TIME, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS DEFECT.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT#: 220407, MEDICAL DEVICE EXPIRATION DATE: 31MAR2027, DEVICE MANUFACTURE DATE: 02APR2022. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICROLANCE¿3 NEEDLES THE NEEDLE WOULD NOT ASPIRATE AROUND A CLOG. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: DIFFICULT TO DRAW UP MEDICATIONS. DETAILED DESCRIPTION, SEE ATTACHMENT (ORIGINAL MESSAGE). WITH THE CANNULA COULD NOT BE DRAWN UP DRUG. ONLY DROPS COME. THIS HAS HAPPENED WITH SEVERAL CANNULAS. WHEN COMPARING WITH A CANNULA THAT WORKS, IT IS APPARENT THAT THE HOLE AT THE TRANSITION FROM THE YELLOW BASE TO THE METAL TUBE IS NOT QUITE SHARPLY DEFINED AND CANNOT BE SEEN THROUGH AGAINST A LIGHT SOURCE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICROLANCE¿3 NEEDLES THE NEEDLE WOULD NOT ASPIRATE AROUND A CLOG. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: DIFFICULT TO DRAW UP MEDICATIONS. DETAILED DESCRIPTION, SEE ATTACHMENT (ORIGINAL MESSAGE). WITH THE CANNULA COULD NOT BE DRAWN UP DRUG. ONLY DROPS COME. THIS HAS HAPPENED WITH SEVERAL CANNULAS. WHEN COMPARING WITH A CANNULA THAT WORKS, IT IS APPARENT THAT THE HOLE AT THE TRANSITION FROM THE YELLOW BASE TO THE METAL TUBE IS NOT QUITE SHARPLY DEFINED AND CANNOT BE SEEN THROUGH AGAINST A LIGHT SOURCE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICROLANCE¿3 NEEDLES THE NEEDLE WOULD NOT ASPIRATE AROUND A CLOG. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: DIFFICULT TO DRAW UP MEDICATIONS. DETAILED DESCRIPTION, SEE ATTACHMENT (ORIGINAL MESSAGE). WITH THE CANNULA COULD NOT BE DRAWN UP DRUG. ONLY DROPS COME. THIS HAS HAPPENED WITH SEVERAL CANNULAS. WHEN COMPARING WITH A CANNULA THAT WORKS, IT IS APPARENT THAT THE HOLE AT THE TRANSITION FROM THE YELLOW BASE TO THE METAL TUBE IS NOT QUITE SHARPLY DEFINED AND CANNOT BE SEEN THROUGH AGAINST A LIGHT SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2316511 BD MICROLANCE¿3 NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 220536

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown