BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD® BLUNT FILL NEEDLE

    MDR report key: 17471456 · Received August 7, 2023

    Report

    Report Number
    3002682307-2023-00226
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    July 17, 2023
    Report Date
    October 3, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    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

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBER 221206. 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, FORTY (40) UNUSED NEEDLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE NEEDLES WERE USED TO PUNCTURE A LABORATORY VIAL (PLASTIC STOPPER) AND NO DIFFICULTIES WERE IDENTIFIED. AFTER PUNCTURING THE VIAL, THE NEEDLES WERE MICROSCOPICALLY EXAMINED. NO PARTICLES WERE OBSERVED TO INDICATE VIAL STOPPER FRAGMENTATION AND THE BEVELS MAINTAINED PROPER FORM. BASED ON THE PREVENTIVE MEASURES IN PLACE, IT IS UNLIKELY THAT CORING RESULTED FROM POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA. IT IS POSSIBLE THAT THE STOPPER CONDITIONS AND THE HANDLING OF THE PRODUCT HAD A ROLE IN THE REPORTED 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, 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.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. 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 WHILE USING THE BD® BLUNT FILL NEEDLE A FRAGMENT OF RUBBER PASSED INTO THE SYRINGE. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT DESCRIPTION: "THE INCIDENT IS REPORTED TO SINEA (ADVERSE EVENT REPORTING SYSTEM), BY AN ANESTHESIOLOGIST IN THE OPERATING ROOM: "WHEN LOADING THE REMIFENTANIL I NOTICED A FRAGMENT OF RUBBER THAT HAD PASSED INTO THE SYRINGE FROM THE PUNCTURE OF THE VIAL WITH THE THICK LOADING NEEDLE. IT IS A FRAGMENT THAT IS DIFFICULT TO SEE AND IS VERY LIKELY TO GO UNNOTICED WHEN LOADING MANY TYPES OF MEDICATION. WE ALSO DETECTED THE PROBLEM WITH PROPOFOL LOADING MORE THAN A MONTH AGO (B)(6) 2023)." CONSEQUENCES FOR THE PATIENT: NONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD® BLUNT FILL NEEDLE A FRAGMENT OF RUBBER PASSED INTO THE SYRINGE. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT DESCRIPTION: "THE INCIDENT IS REPORTED TO SINEA (ADVERSE EVENT REPORTING SYSTEM), BY AN ANESTHESIOLOGIST IN THE OPERATING ROOM: "WHEN LOADING THE REMIFENTANIL I NOTICED A FRAGMENT OF RUBBER THAT HAD PASSED INTO THE SYRINGE FROM THE PUNCTURE OF THE VIAL WITH THE THICK LOADING NEEDLE. IT IS A FRAGMENT THAT IS DIFFICULT TO SEE AND IS VERY LIKELY TO GO UNNOTICED WHEN LOADING MANY TYPES OF MEDICATION. WE ALSO DETECTED THE PROBLEM WITH PROPOFOL LOADING MORE THAN A MONTH AGO ( (B)(6) 2023)." CONSEQUENCES FOR THE PATIENT: NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158684 BD® BLUNT FILL NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 221206

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown