BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ NEEDLE

    MDR report key: 15567758 · Received October 7, 2022

    Report

    Report Number
    3002682307-2022-00264
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    September 2, 2022
    Report Date
    November 22, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903851027
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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-OCT-2022 . H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304622 AND LOT NUMBER 200101. 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, NINETEEN (19) PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, A RED PARTICLE COULD BE SEEN WITHIN THE SYRINGE ALONGSIDE A VIAL OF MEDICATION. EIGHTY-EIGHT (88) PHYSICAL SAMPLES FROM LOT NUMBER 200101 WERE RECEIVED AS WELL AS FOUR (4) PHYSICAL SAMPLES FROM LOT NUMBER 190924 AND SIXTEEN (16) SAMPLES FROM LOT NUMBER 210316. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THESE ADDITIONAL SAMPLE LOTS, AND NO ABNORMALITIES WERE FOUND DURING THE PRODUCTION PROCESS. THE PHYSICAL SAMPLES WERE VISUALLY EXAMINED AND NO SIGNS OF DEFECT WERE OBSERVED. THE NEEDLES WERE TESTED FOR FUNCTIONALITY BY PUNCTURING A TEST VIAL. UPON PUNCTURE, THE SAMPLES WERE MICROSCOPICALLY EXAMINED; HOWEVER, NO DEFECTS WERE IDENTIFIED. BASED ON THE INVESTIGATION RESULTS AND TAKING INTO ACCOUNT THE PREVENTIVE MEASURES IN PLACE DURING THE CANNULA MANUFACTURING PROCESS, WE BELIEVE THE REPORTED INCIDENT OF CORING WAS UNLIKELY TO HAVE BEEN CAUSED BY POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA COMPONENT. AS PART OF THE CANNULA INSPECTION PROCESS, PRODUCTS ARE SUBJECTED TO VISUAL INSPECTIONS, MEASUREMENTS, AND PENETRATION TESTS. IT IS POSSIBLE THAT THE STOPPER CONDITIONS HAD A ROLE IN THIS INCIDENT AS STORAGE CONDITIONS COULD AFFECT THE FRAGMENTATION OF THE RUBBER. IT IS ALSO POSSIBLE THAT THE HANDLING OF THE PRODUCT CONTRIBUTED TO THE REPORTED INCIDENT. THE NEEDLE SHOULD PENETRATE THE VIAL STOPPER AT A NINETY-DEGREE ANGLE TO REDUCE THE RISK OF THE NEEDLE CATCHING THE INTERNAL WALL OF THE STOPPER. AT THIS TIME, AN EXACT CAUSE CANNOT BE DETERMINED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PARTICLES WERE FOUND IN THE VIAL AFTER THE BD MICROLANCE¿ NEEDLE WAS USED TO PUNCTURE IT AND DRAW UP MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REPORTS FROM DR THAT HYPOTHERMIC PINK NEEDLES THAT TINY PARTICLES BROKE OFF AND WERE FOUND FLOATING IN MEDICATION TO BE DELIVERED TO CHILDREN IN OUR CARE IN THEATRE . EVIDENCE OF THE PARTICLES FROM THESE NEEDLES FLOATING IN THE SYRINGE AFTER THE MEDICATION WAS DRAWN UP USING THEM. BEFORE USE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PARTICLES WERE FOUND IN THE VIAL AFTER THE BD MICROLANCE¿ NEEDLE WAS USED TO PUNCTURE IT AND DRAW UP MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REPORTS FROM DR THAT HYPOTHERMIC PINK NEEDLES THAT TINY PARTICLES BROKE OFF AND WERE FOUND FLOATING IN MEDICATION TO BE DELIVERED TO CHILDREN IN OUR CARE IN THEATRE. EVIDENCE OF THE PARTICLES FROM THESE NEEDLES FLOATING IN THE SYRINGE AFTER THE MEDICATION WAS DRAWN UP USING THEM BEFORE USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289164 BD MICROLANCE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 200101 00382903851027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown