BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 25GA 1IN

    MDR report key: 12892980 · Received November 30, 2021

    Report

    Report Number
    3002682307-2021-00632
    Event Type
    Malfunction
    Date Received
    November 30, 2021
    Date of Event
    July 26, 2021
    Report Date
    December 16, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 200911. 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, BOTH A PICTURE AND PHYSICAL SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE SAMPLE, CANNULA POINT DAMAGE COULD NOT BE OBSERVED. THE PHYSICAL SAMPLE WAS MICROSCOPICALLY EXAMINED AND WE COULD CONFIRM THAT THE CANNULA POINT HAD A WELL-FORMED BEVEL, WITH NO SIGNS OF BLUNT POINT OR DAMAGE. THE NEEDLE WAS THEN ASSEMBLED WITH A BD EMERALD SYRINGE TO TEST FOR THE REPORT OF AIR BUBBLES. DURING USE, THE NEEDLE WAS OBSERVED CLOGGED. A SMALL PORTION OF THE CLOGGED MATERIAL WAS REMOVED AND PREPARED FOR FOURIER-TRANSFORM INFRARED SPECTROSCOPY. THE SPECTRAL ANALYSIS SHOWED THAT THE MATERIAL WAS MOST LIKELY SUCROSE IN KBR. THIS TYPE OF MATERIAL WOULD NOT COME FROM THE MANUFACTURING PROCESS; THEREFORE, WE BELIEVE THE CLOGGED NEEDLE RESULTED FROM THE DRUG REMAINING IN THE NEEDLE FOR AN EXTENDED PERIOD OF TIME. PER THE PROVIDED FEEDBACK, WE UNDERSTAND AN ISSUE OF BLUNT POINT NEEDLE COULD HAVE TAKEN PLACE. DURING THE ASSEMBLY PROCESS, AN IN-LINE CAMERA SYSTEM INSPECTS ALL PRODUCT FOR SIGNS OF DEFECT AND AUTOMATICALLY REJECTS ANY FAULTY PRODUCT. CANNULA POINT CONDITION IS TESTED EVERY THIRTY MINUTES AND A PENETRABILITY TEST IS PERFORMED FOR EACH LOT RELEASED. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. THE CANNULA IS THE MOST CRITICAL AND FRAGILE POINT OF THE NEEDLE AND CAN BECOME DAMAGED VERY EASILY. THE NEEDLE SHOULD BE INSERTED INTO THE VIAL AT A NINETY-DEGREE ANGLE, THE NEEDLE SHOULD NOT BE MANIPULATED WITHIN THE VIAL, AND THE USER SHOULD AVOID RECAPPING THE NEEDLE AFTER DRAWING. THESE PRACTICES WILL HELP TO PREVENT THE RISK OF DAMAGE TO THE CANNULA POINT. THE ISSUE OF AIR BUBBLES DURING ASPIRATION COULD NOT BE REPRODUCED; HOWEVER, CLOGGED NEEDLE WAS OBSERVED. NEEDLES ARE INSPECTED FOR SIGNS OF OCCLUSION EVERY THIRTY MINUTES AS PART OF THE IN-PROCESS INSPECTION AFTER ASSEMBLY. IN CERTAIN CIRCUMSTANCES, THE DRUG USED CAN BECOME DEPOSITED WITHIN THE CANNULA, CAUSING THE NEEDLE TO BLOCK DUE TO CRYSTALLIZATION. OCCLUSION IS MOST LIKELY TO OCCUR IF THE DRUG REMAINS IN THE NEEDLE FOR AN EXTENDED PERIOD OF TIME. BASED ON THESE CONCLUSIONS, WE CANNOT DISCARD THE POSSIBILITY THAT THE HANDLING OF THE PRODUCT HAD A ROLE IN THE OBSERVED DEFECT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD NEEDLE 25GA 1IN, THE DEVICE EXPERIENCED A CLOGGED OR BLOCKED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER USES THIS PRODUCT FOR COVID-19 VACCINATION. (1) NEEDLE POINT CONFIGURATION: THE HCP FELT RESISTANCE AND DIDN'T INSERT THE NEEDLE INTO THE VIAL SMOOTHLY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD NEEDLE 25GA 1IN, THE DEVICE EXPERIENCED A CLOGGED OR BLOCKED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER USES THIS PRODUCT FOR COVID-19 VACCINATION. (1) NEEDLE POINT CONFIGURATION: THE HCP FELT RESISTANCE AND DIDN'T INSERT THE NEEDLE INTO THE VIAL SMOOTHLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792475 BD NEEDLE 25GA 1IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 200911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown