BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXEL HYPO NDL 27GX1-1/4"

    MDR report key: 19126746 · Received April 17, 2024

    Report

    Report Number
    1035907-2024-00015
    Event Type
    Injury
    Date Received
    April 17, 2024
    Date of Event
    July 14, 2022
    Report Date
    April 8, 2024
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    UDI-DI
    20221264272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REFUSED TO RETURN ANY SAMPLES AND THE DETAILS; FACTORY HAD CONDUCTED THE INVESTIGATION WITH THE LOT RETAIN SAMPLES THEY HAD SINCE ARE AS FOLLOWS: 1. LOT RETAIN SAMPLE INSPECTION: 20 SAMPLES FROM THIS LOT WERE CHOSEN FOR VISUAL INSPECTION. THE ADHESIVE BETWEEN THE NEEDLE TUBE AND THE NEEDLE BASE IS IN THE RIGHT AMOUNT. IN ADDITION, FIVE SAMPLE 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. 2. PRODUCTION 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: 1. NO OTHER COMPLAINTS RELATED TO THIS PRODUCT WERE REPORTED TO EXEL EXCEPT FOR THIS CUSTOMER. 2. THERE WAS NO ANSWER GIVEN BY THE CUSTOMER ABOUT THE USAGE OF THE DEVICE AS PER THE IFU. 3. THE CUSTOMER REPORTED ANOTHER INCIDENT 5 DAYS AFTER THE INITIAL INCIDENT REGARDING THE NEEDLES BEING BENT SHOWING THAT THEY HAD THE SAMPLES PRESENT. 4. NO SAMPLES WERE RETURNED MAKING IT DIFFICULT TO TEST THE PRODUCT LOT THAT WAS DELIVERED. THROUGH THE INSPECTION OF THE LOT RETAIN SAMPLES AND THE RETROSPECTIVE REVIEW OF PRODUCTION RECORDS, THE PRODUCT APPEARS TO MEET THE STANDARD REQUIREMENTS. AS THE DEVICE WAS NOT RETURNED NOR IMAGES PROVIDED, THE FOLLOWING COULD BE THE POTENTIAL REASONS FOR THE NONCONFORMANCE: 1. DURING CLINICAL USE, IF THE TOLERANCE RANGE OF THE NEEDLE TUBE BENDING EXCEEDS 20°, THERE IS A RISK OF NEEDLE TUBE FRACTURE. 2. 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. 3. THERE IS NO ADHESIVE OR LACK OF ADHESIVE BETWEEN NEEDLE TUBE AND NEEDLE BASE. CAPA-33 WAS INITIATED TO INVESTIGATE AND IMPLEMENT METHODS TO ADDRESS NEEDLE BREAKAGE IN PATIENTS. (B)(4)

    Description of Event or Problem · 0

    THE FOLLOWING IS A LEGACY COMPLAINT(B)(4) THAT WAS INVESTIGATED AND CLOSED IN 2022 BUT IS BEING RE-OPENED IN QUALIO BECAUSE THE INCIDENT SHOULD HAVE ORIGINALLY BEEN A REPORTABLE EVENT. REFERENCE CAPA-34 FOR EXPLANATION. ON 14-JUL-2022 THE CUSTOMER STATED, "LOT #210511 WAS USED FOR THE PROCEDURE. I'D LIKE TO ADD THAT WE HAVE BEEN HAVING RECURRING ISSUES WITH THE DISPOSABLE NEEDLES. THE PHYSICIANS WERE COMPLAINING ABOUT THE QUALITY. YESTERDAY WAS A VERY SEVERE CASE. WHILE THE PHYSICIANS WAS USING THE 27G X 1/4 NEEDLE, THE NEEDLE SNAPPED OFF INSIDE OF THE PATIENTS BODY [BUTTOCKS]." THE CUSTOMER NOTED THE HYPODERMIC NEEDLE WAS BEING USED TO INJECT ANESTHESIA AND WAS NOT ABLE TO BE EXTRACTED. THE CUSTOMERS OFFICE MANAGER ADDED, "PATIENT WAS SENT TO THE HOSPITAL ER FOR REMOVAL OF THE NEEDLE. UNFORTUNATELY, THE NEEDLE WAS NOT ABLE TO BE REMOVED. PATIENT IS NOW SCHEDULED TO SEE A PLASTIC SURGEON." LASTLY, THE CUSTOMER COMPLAINED THAT THE NEEDLE BEND AT THE HUB DURING USE AND WERE DIFFICULT TO MANEUVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1975665 EXEL HYPO NDL 27GX1-1/4" HYPODERMIC NEEDLE FMF EXELINT INTERNATIONAL, CO. 26427 210511 20221264272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization