BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD® BLUNT FILL NEEDLE 18 G X 1 1/2 IN

    MDR report key: 17466697 · Received August 4, 2023

    Report

    Report Number
    1911916-2023-00541
    Event Type
    Malfunction
    Date Received
    August 4, 2023
    Date of Event
    July 13, 2023
    Report Date
    October 3, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051800
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBER 230203. 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. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY (20) RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR EVALUATION. THE NEEDLES WERE MICROSCOPICALLY EXAMINED AND NO SIGNS OF DEFECT WERE OBSERVED. THE NEEDLES WERE THEN USED TO PUNCTURE A LABORATORY VIAL (PLASTIC STOPPER) AND NO DIFFICULTIES WERE IDENTIFIED. AFTER PUNCTURING THE VIAL, THE NEEDLES WERE AGAIN 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD® BLUNT FILL NEEDLE 18 G X 1 1/2 IN FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SMALL BLACK RUBBER PARTS WERE FOUND IN THE SYRINGE AFTER REFILLING WITH A PROPOFOL GLASS VIAL. BLUNT NEEDLE WAS USED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD® BLUNT FILL NEEDLE 18 G X 1 1/2 IN FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SMALL BLACK RUBBER PARTS WERE FOUND IN THE SYRINGE AFTER REFILLING WITH A PROPOFOL GLASS VIAL. BLUNT NEEDLE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899313 BD® BLUNT FILL NEEDLE 18 G X 1 1/2 IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown