BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL NEEDLE 22GA 3.50 IN

    MDR report key: 10646735 · Received October 7, 2020

    Report

    Report Number
    3003152976-2020-00435
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    September 16, 2020
    Report Date
    October 29, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 9/22/2020. H.6. INVESTIGATION: TWO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO FOREIGN MATTER OR OTHER CONTAMINATION WAS OBSERVED ON THE CANNULA, STYLET, NEEDLE HUB, OR NEEDLE SHIELD. ADDITIONALLY THE PACKAGING WAS EVALUATED AND NO FOREIGN MATTER WAS FOUND INSIDE THE PACKAGE, HOWEVER, BROWN SPOTS WERE OBSERVED ON THE OUTSIDE OF THE UNIT PACKAGE ON ONE SAMPLE. FURTHER EVALUATION IDENTIFIED THE SPOTS WERE LIKELY FROM THE OUTER CARTON PACKAGE THAT THE SAMPLES WERE SENT IN, NO DEFECT OR CONTAMINATION RELATED TO OUR PRODUCT OR PROCESS WAS OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1910005, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SPINAL NEEDLE 22GA 3.50 IN HAD MOLD ON 18 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BD SPINAL NEEDLES WERE NOTED TO BE HAVING SOME MOULDS AT AKUH THEATRE AND WERE SUBSEQUENTLY RETURNED TO THE DISTRIBUTOR SURGIPHARMA. FOUR INCIDENTS OF CSF CONTAMINATIONS WERE ESTABLISHED AFTER THE LUMBAR PUNCTURE (LP) PROCEDURES. THE LP'S WERE PERFORMED BY DIFFERENT INDIVIDUALS IN DIFFERENT IN SITES AT THE INSTITUTION. THE HOSPITAL IS AUDITING ALL THE PROCESSES AND EQUIPMENTS USED INCLUDING THE BD SPINAL NEEDLES G22, WHICH WERE A COMMON DENOMINATOR ACROSS ALL THE FOUR INCIDENTS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SPINAL NEEDLE 22 GA 3.50 IN HAD MOLD ON 18 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BD SPINAL NEEDLES WERE NOTED TO BE HAVING SOME MOULDS AT AKUH THEATRE AND WERE SUBSEQUENTLY RETURNED TO THE DISTRIBUTOR SURGIPHARMA. FOUR INCIDENTS OF CSF CONTAMINATIONS WERE ESTABLISHED AFTER THE LUMBAR PUNCTURE (LP) PROCEDURES. THE LP'S WERE PERFORMED BY DIFFERENT INDIVIDUALS IN DIFFERENT IN SITES AT THE INSTITUTION. THE HOSPITAL IS AUDITING ALL THE PROCESSES AND EQUIPMENTS USED INCLUDING THE BD SPINAL NEEDLES G22, WHICH WERE A COMMON DENOMINATOR ACROSS ALL THE FOUR INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111203 SPINAL NEEDLE 22GA 3.50 IN NEEDLE FMI BECTON DICKINSON, S.A. 1910005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other