BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD® QUINCKE SPINAL NEEDLES 27G

    MDR report key: 16244427 · Received January 25, 2023

    Report

    Report Number
    3003152976-2023-00005
    Event Type
    Malfunction
    Date Received
    January 25, 2023
    Date of Event
    September 9, 2022
    Report Date
    February 8, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382904052591
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2111005, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THREE RETAINED SAMPLES OF THE REPORTED LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCTS WERE VISUALLY INSPECTED AND NO DAMAGE OR BENT NEEDLES WERE OBSERVED. PRODUCT UNDERGOES VISUAL INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS ACCORDING TO PROCEDURE, VERIFYING THERE ARE NO DEFECTS OR DAMAGE ON THE PRODUCT. LOT RELEASE TESTING RESULTS WERE REVIEWED FOR THE REPORTED LOT AND NO ISSUES WERE IDENTIFIED. BASED ON OUR INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME.

    Additional Manufacturer Narrative · 0

    PATIENT¿S BIRTHDAY WAS NOT PROVIDED, (B)(6) WAS USED BASED ON AGE OF PATIENT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD® QUINCKE SPINAL NEEDLES 27G THE CATHETER COULD NOT THREAD THROUGH THE NEEDLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WHEN PERFORMING THE PUNCTURE, THE PLASTIC PART IS BENT AT THE JUNCTION OF THE NEEDLE; THE MANDREL DOES NOT SLIP ON THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD® QUINCKE SPINAL NEEDLES 27G THE CATHETER COULD NOT THREAD THROUGH THE NEEDLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WHEN PERFORMING THE PUNCTURE, THE PLASTIC PART IS BENT AT THE JUNCTION OF THE NEEDLE; THE MANDREL DOES NOT SLIP ON THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1110282 BD® QUINCKE SPINAL NEEDLES 27G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 2111005 00382904052591

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male