BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE 3/8 CIRCLE REVERSE CUTTING, .027X.827, STERILE

    MDR report key: 10373600 · Received August 6, 2020

    Report

    Report Number
    1836161-2020-00037
    Event Type
    Injury
    Date Received
    August 6, 2020
    Date of Event
    July 10, 2020
    Report Date
    July 10, 2020
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    GAB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR THAT A NEEDLE BROKE DURING A PROCEDURE. INCIDENT OCCURRED AT THE END USER. THE ACTUAL DEVICE WAS DETERMINED TO BE AVAILABLE FOR EVALUATION ALONG WITH THE MANUFACTURING LOT NUMBER. A REVIEW OF THE SAMPLE CONFIRMED THE ISSUE FROM THE DISTRIBUTOR. ANALYSIS OF THE FINISHED GOOD LOT NUMBER WAS REVIEWED. NO NON-CONFORMANCE'S WERE NOTED DURING THE MANUFACTURING PROCESS. CUSTOMER REPORTED THAT DURING A PROCEDURE, THE TIP OF THE NEEDLE BROKE AT TIME OF USE. THE DOCTOR WAS ABLE TO RETRIEVE THE BROKEN OFF TIP OUT OF THEIR PATIENT WITHOUT ISSUE. ACCORDING TO ASPEN SURGICAL'S IFU, THE NEEDLES SHOULD NOT BE CLAMPED DIRECTLY ON THE EYE OF THE NEEDLE TO THE POINT AND SHOULD BE APPLIED TO THE FLAT PORTION OF THE NEEDLE ABOUT 1/4 OF THE NEEDLE LENGTH FROM THE EYE END. A REVIEW OF THE SAMPLES RETURNED SHOW THAT THE NEEDLES WERE CLAMPED IMPROPERLY EITHER NOT ON THE FLAT SIDE OR TOO CLOSE TO THE EYE OR POINT, WHICH LIKELY CAUSED THEM TO BREAK. BASED ON THIS INFORMATION, THE ROOT CAUSE IS ATTRIBUTED TO CUSTOMER MISUSE AND NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT A NEEDLE BROKE DURING A PROCEDURE. INCIDENT OCCURRED AT THE END USER. THIS EVENT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE ON THE PRODUCT AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT A NEEDLE BROKE DURING A PROCEDURE. INCIDENT OCCURRED AT THE END USER. THIS EVENT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS NUMBER C-1180872.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835845 NEEDLE 3/8 CIRCLE REVERSE CUTTING, .027X.827, STERILE SURGICAL NEEDLE GAB ASPEN SURGICAL PRODUCTS, CALEDONIA 209020 138772

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R