BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLUNT FILL NEEDLE 18G 1 1/2IN

    MDR report key: 17406465 · Received July 27, 2023

    Report

    Report Number
    3002682307-2023-00210
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    July 5, 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
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 25-SEP-2023. H.6. 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) SHELF CARTONS AND TWO (2) PLASTIC BAGS OF PRODUCT WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. TWENTY (20) NEEDLE SAMPLES WERE RANDOMLY SELECTED FOR A THOROUGH EXAMINATION. 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 THAT DURING USE WITH BD BLUNT FILL NEEDLE 18G 1 1/2IN CORING OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CORING. PIECES OF RUBBER STARTED COMING OFF THE MEDICINE GLASS BOTTLE WHEN THE RUBBER STOPPER WAS PIERCED. DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD BLUNT FILL NEEDLE 18G 1 1/2IN CORING OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CORING. PIECES OF RUBBER STARTED COMING OFF THE MEDICINE GLASS BOTTLE WHEN THE RUBBER STOPPER WAS PIERCED. DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222886 BD BLUNT FILL NEEDLE 18G 1 1/2IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 230202

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown