BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD® QUINCKE SPINAL NEEDLE 27GA 3.50 IN

    MDR report key: 14135427 · Received April 18, 2022

    Report

    Report Number
    3003152976-2022-00147
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 24, 2022
    Report Date
    May 2, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    BSP
    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

    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 WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 25-APR-2022. H6: INVESTIGATION SUMMARY: ONE PHOTO AND THREE UNIT PACKS HAVE BEEN PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. AFTER VISUAL INSPECTION OF BOTH THE PHOTOGRAPHS AND PHYSICAL SAMPLES, IT WAS OBSERVED THAT THE PEEL TAB OF THE PACKAGE WAS SEALED, PREVENTING PROPER OPENING OF THE PACKAGE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2201009, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THIS ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. PACKAGING PARAMETERS ARE SET AND VALIDATED ACCORDING TO PROCEDURE. PRODUCT UNDERGOES TESTING AND INSPECTIONS THROUGHOUT MANUFACTURING, ALL RESULTS WERE REVIEWED FOR LOT 2201009 AND VERIFIED MACHINE AND PACKAGING PARAMETERS WERE WITHIN REQUIRED LIMITS, AND RESULTS OF THE OF THE PEEL TAB INSPECTION WAS ACCEPTABLE. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, THIS INCIDENT CAN OCCUR DUE TO AN ERROR IN THE PACKAGING MACHINE CAUSING THE CROSS CUTTING BLADES TO MOVE AND CUT IN THE INCORRECT LOCATION, RESULTING IN THE PEEL TAB REMAINING SEALED.

    Description of Event or Problem · 0

    IT WAS REPORTED BD® QUINCKE SPINAL NEEDLE 27GA 3.50 IN HAD POOR PERFORATION ON THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "...PROBLEM IN OPENING THE PRODUCT STERILE BECAUSE THE END INTENDED TO OPEN THE NEEDLE PACK IS STUCK TOGETHER. SO THE PART WHERE A SINGLE SPINAL NEEDLE PACK SHOULD BE TORN OPEN."

    Description of Event or Problem · 0

    IT WAS REPORTED BD® QUINCKE SPINAL NEEDLE 27GA 3.50 IN HAD POOR PERFORATION ON THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "...PROBLEM IN OPENING THE PRODUCT STERILE BECAUSE THE END INTENDED TO OPEN THE NEEDLE PACK IS STUCK TOGETHER. SO THE PART WHERE A SINGLE SPINAL NEEDLE PACK SHOULD BE TORN OPEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818321 BD® QUINCKE SPINAL NEEDLE 27GA 3.50 IN ANESTHESIA CONDUCTION NEEDLE BSP BECTON DICKINSON, S.A. 2201009

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown