BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD® BLUNT FILL NEEDLE

    MDR report key: 17213944 · Received June 27, 2023

    Report

    Report Number
    3002682307-2023-00172
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    June 2, 2023
    Report Date
    September 12, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903031290
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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: 04-JUL-2023. H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBER 230202. 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, TWO (2) BLUNT NEEDLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE NEEDLES WERE EXAMINED UNDER A MICROSCOPE AND NO DAMAGE WAS OBSERVED TO THE BEVEL. THE NEEDLES WERE TESTED USING A LABORATORY VIAL WITH A PLASTIC STOPPER; HOWEVER, NO DIFFICULTIES WERE DETECTED. AFTER VIAL PUNCTURE TESTING, THE NEEDLES WERE AGAIN EXAMINED UNDER MICROSCOPE AND NO PARTICLES FROM VIAL STOPPER FRAGMENTATION WERE FOUND AND THE BEVELS REMAINED IN GOOD FORM. BASED ON THE PREVENTIVE MEASURES IN PLACE, IT IS UNLIKELY THAT THE CORING EFFECT RESULTED FROM POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA DURING MANUFACTURE.

    Additional Manufacturer Narrative · 0

    H.3. 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® BLUNT FILL NEEDLE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING USE. WHEN PRICKING A VIAL WITH THE NEEDLE, PIECES OR RUBBER HAVE BEEN LEFT INSIDE IT. THEY ARE ALSO EVALUATING THE QUALITY OF THE VIAL'S RUBBER. *PICTURE OF THE PACKAGE AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD® BLUNT FILL NEEDLE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING USE. WHEN PRICKING A VIAL WITH THE NEEDLE, PIECES OR RUBBER HAVE BEEN LEFT INSIDE IT. THEY ARE ALSO EVALUATING THE QUALITY OF THE VIAL'S RUBBER. *PICTURE OF THE PACKAGE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725550 BD® BLUNT FILL NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 230202 00382903031290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown