BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXEL HYPO NDL 27G X 1-½"

    MDR report key: 19047824 · Received April 4, 2024

    Report

    Report Number
    1035907-2024-00011
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    August 25, 2022
    Report Date
    April 4, 2024
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    UDI-DI
    20221264265
    PMA / PMN Number
    K861153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE CUSTOMER HAD NO DEFECTIVE SAMPLES TO RETURN; FACTORY HAD CONDUCTED THE INVESTIGATION WITH THE LOT RETAIN SAMPLES THEY HAD SINCE ARE AS FOLLOWS: BATCH SAMPLE TESTING: 20 PIECES OF THIS BATCH OF RESERVED SAMPLES WERE SELECTED, AND VISUAL INSPECTION WAS CARRIED OUT. THE ADHESIVE BETWEEN THE NEEDLE TUBE AND NEEDLE SEAT IS IN THE RIGHT AMOUNT. IN ADDITION, FIVE NEEDLES WERE SELECTED FOR THE RIGIDITY AND TOUGHNESS OF THE NEEDLE TUBES AND THE FIRMNESS OF THE NEEDLE TUBE CONNECTION, AND THEY PASSED THE TESTING MEETING THE REQUIREMENTS OF ISO 9626:2016. PRODUCT PROCESS REVIEW: THE PRODUCTION LOT RECORD AND THE FINISHED PRODUCT DELIVERY INSPECTION REPORT OF THIS LOT ARE TRACED, AND NO ABNORMALITIES HAVE BEEN FOUND IN THE PRODUCTION PROCESS AND THE FINISHED PRODUCT INSPECTION PROCESS. IN ADDITION TO THE ABOVE INVESTIGATION FROM THE FACTORY, THE FOLLOWING DETAILS ARE FOUND: NO OTHER COMPLAINTS RELATED TO THIS PRODUCT WERE REPORTED TO EXEL EXCEPT FOR THIS CUSTOMER. THERE WAS NO ANSWER GIVEN BY THE CUSTOMER ABOUT THE USAGE OF THE DEVICE AS PER THE IFU. NO DEFECTIVE SAMPLES WERE RETURNED MAKING IT DIFFICULT TO TEST THE PRODUCT LOT THAT WAS DELIVERED. RESULTS/CONCLUSIONS: THROUGH THE INSPECTION OF THE LOT RETAIN SAMPLES AND THE RETROSPECTIVE INVESTIGATION AS DISCUSSED ABOVE, THE PRODUCT APPEARS TO MEET THE STANDARD REQUIREMENTS. THE FOLLOWING COULD BE THE POTENTIAL REASONS FOR THE NONCONFORMANCE: DURING CLINICAL USE, IF THE TOLERANCE RANGE OF THE NEEDLE TUBE BENDING EXCEEDS 20°, THERE IS A RISK OF NEEDLE TUBE FRACTURE. HENCE, THE CLINICIANS SHOULD FOLLOW IFU. IF THE TUBE WAS CUT OR DAMAGED WITH SHARP OBJECT, LIKE A KNIFE OR BLADE, THE SURFACE OF THE NEEDLE TUBE IS COMPROMISED, AND THE NEEDLE TUBE MAY BE BROKEN. CAPA-33 HAS BEEN OPENED TO INVESTIGATE NEEDLE BREAKAGE INCIDENTS.

    Description of Event or Problem · 0

    THE FOLLOWING IS A LEGACY COMPLAINT (B)(6) THAT WAS INVESTIGATED AND CLOSED IN 2022 BUT IS BEING RE-OPENED BECAUSE IT WAS RECENTLY DETERMINED THAT THE INCIDENT SHOULD HAVE ORIGINALLY BEEN A REPORTABLE EVENT. REFERENCE (B)(6) FOR EXPLANATION. ON (B)(6) 2022 AN EMAIL WAS SENT TO EXEL QA FROM, AIR-TITE PRODUCTS, THE FOLLOWING: "WE RECEIVED A REPORT FROM ONE OF OUR MUTUAL CUSTOMERS THAT A DOCTOR PROVIDED AN INJECTION WITH THE REFERENCED 27G X 1-1/2" NEEDLE AND THE NEEDLE BROKE OFF INSIDE OF THE PATIENT.' THE PATIENT NEEDED TO GO TO THE EMERGENCY ROOM TO HAVE THE NEEDLE FRAGMENT REMOVED UNDER FLUOROSCOPY. I DO NOT BELIEVE THERE ARE ANY IMAGES AVAILABLE OR SAMPLES TO RETURN." THE PRODUCT IN QUESTION IS ITEM # 26426, LOT # 210415.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83193 EXEL HYPO NDL 27G X 1-½" HYPODERMIC NEEDLE FMF EXELINT INTERNATIONAL, CO. 210415 20221264265

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H