BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL NEEDLE 25GA 3.50 IN FOR INDIA

    MDR report key: 10834791 · Received November 13, 2020

    Report

    Report Number
    3003152976-2020-00502
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 19, 2020
    Report Date
    December 4, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: ONE PHOTO SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PHOTO DISPLAYS A SPINAL NEEDLE FROM LOT 1910023, PRODUCT 405122 INSIDE IT IS ORIGINAL UNITARY SEALED PACKAGE. THERE IS NO DAMAGE OR OTHER DEFECTS OBSERVED IN THE PHOTO THAT COULD HAVE LEAD TO THE LEAK REPORTED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1910023, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FIVE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR CRACKS WERE OBSERVED ON OR NEAR THE LUER CONNECTION. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE NEEDLE TO A SYRINGE. LIQUID WAS ABLE TO PASS FROM THE SYRINGE THROUGH THE NEEDLE AND NO LEAKAGE WAS OBSERVED. PRODUCT IS VISUALLY AND FUNCTIONALLY TESTED THROUGHOUT MANUFACTURING ACCORDING TO PROCEDURE, VERIFYING ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. TESTING RESULTS VERIFIED PRODUCT MET ALL REQUIRED LIMITS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 50 SPINAL NEEDLE 25GA 3.50 IN FOR INDIA EXPERIENCED THE NEEDLE AND MATING COMPONENT SEPARATING/SPINNING OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE USER HAS USED SPINAL NEEDLE QUINCKE BEFORE. BUT HAS FACED DISCONNECTION/LEAKAGE ISSUES WITH THE RECENT LOT PURCHASE. THE LEAKAGE OCCURRED WHILE DOING THE LAP CHOLE SURGERY WHILE SUPPLYING ANESTHESIA THROUGH THE QUINCKE NEEDLE USING THE DISCARDIT 5 ML SYRINGE. THE USER FACED SOME RESISTANCE WHILE ADMINISTERING THE ANESTHESIA DRUG. WHEN THE USER PUSHED THROUGH THE RESISTANCE TO ADMINISTER THE DRUG THERE WAS SOME LEAKAGE OF THE DRUG FROM THE HUB. DUE TO THE LEAKAGE THERE WAS CONFUSION ABOUT THE ANESTHESIA DOSAGE ADMINISTERED TO THE PATIENT THE ANESTHETIST FACED SOME RESISTANCE WHILE ADMINISTERING THE ANESTHESIA THROUGH THE QUINCKE USING 5ML DISCARDIT SYRINGE. WHEN HE PUSHED THROUGH THERE WAS SOME SPILLAGE OF THE ANESTHESIA DRUG WHICH REDUCED THE DOSAGE OF THE ANESTHESIA TO BE ADMINISTERED TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 50 SPINAL NEEDLE 25GA 3.50 IN FOR INDIA EXPERIENCED THE NEEDLE AND MATING COMPONENT SEPARATING/SPINNING OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE USER HAS USED SPINAL NEEDLE QUINCKE BEFORE. BUT HAS FACED DISCONNECTION/LEAKAGE ISSUES WITH THE RECENT LOT PURCHASE. THE LEAKAGE OCCURRED WHILE DOING THE LAP CHOLE SURGERY WHILE SUPPLYING ANESTHESIA THROUGH THE QUINCKE NEEDLE USING THE DISCARDIT 5 ML SYRINGE. THE USER FACED SOME RESISTANCE WHILE ADMINISTERING THE ANESTHESIA DRUG. WHEN THE USER PUSHED THROUGH THE RESISTANCE TO ADMINISTER THE DRUG THERE WAS SOME LEAKAGE OF THE DRUG FROM THE HUB. DUE TO THE LEAKAGE THERE WAS CONFUSION ABOUT THE ANESTHESIA DOSAGE ADMINISTERED TO THE PATIENT THE ANESTHETIST FACED SOME RESISTANCE WHILE ADMINISTERING THE ANESTHESIA THROUGH THE QUINCKE USING 5ML DISCARDIT SYRINGE. WHEN HE PUSHED THROUGH THERE WAS SOME SPILLAGE OF THE ANESTHESIA DRUG WHICH REDUCED THE DOSAGE OF THE ANESTHESIA TO BE ADMINISTERED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305829 SPINAL NEEDLE 25GA 3.50 IN FOR INDIA NEEDLE FMI BECTON DICKINSON, S.A. 1910023

    Patients

    Seq Age Sex Outcome Treatment
    1