BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELI

    MDR report key: 22518793 · Received July 16, 2025

    Report

    Report Number
    1058382-2025-00002
    Event Type
    Injury
    Date Received
    July 16, 2025
    Report Date
    October 8, 2025
    Manufacturer
    DR, JAPAN CO., LTD.
    Product Code
    BSP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SINCE USING THE RELI NEEDLES A SIGNIFICANT INCREASE IN SPINAL HEADACHES HAS BEEN NOTED BY DR. (B)(6). PHYSICIAN CLAIMS THAT ALTHOUGH THE NEEDLE LENGTH AND GAUGE IS IDENTICAL TO THE PREVIOUS NEEDLE BRAND USED, THERE IS CLEARLY SOMETHING DIFFERENT ABOUT THESE NEEDLES. ONE 7-YEAR-OLD PATIENT WAS HOSPITALIZED FOR 7 DAYS AFTER A LUMBAR PUNCTURE WITH SEVERE SPINAL HEADACHES WHICH REQUIRED TREATMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SINCE USING THE RELI NEEDLES A SIGNIFICANT INCREASE IN SPINAL HEADACHES HAS BEEN NOTED BY DR. (B)(6). PHYSICIAN CLAIMS THAT ALTHOUGH THE NEEDLE LENGTH AND GAUGE IS IDENTICAL TO THE PREVIOUS NEEDLE BRAND USED, THERE IS CLEARLY SOMETHING DIFFERENT ABOUT THESE NEEDLES. ONE 7-YEAR-OLD PATIENT WAS HOSPITALIZED FOR 7 DAYS AFTER A LUMBAR PUNCTURE WITH SEVERE SPINAL HEADACHES WHICH REQUIRED TREATMENT. UPDATE: A DEFECT SAMPLE WAS NOT RETURNED BY THE CUSTOMER FOR REVIEW. THE CUSTOMER CONFIRMED THE ONLY DEVICE INVOLVED WAS THE 1.5" (SN (B)(6)) STATED IN THIS FORM AND WAS THE FOCUS OF THE FACTORY'S INVESTIGATION. ACCORDING TO THE MANUFACTURER'S INVESTIGATION, THE SUSPECT PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF MANUFACTURE. THERE HAVE BEEN NO SIMILAR ISSUES REPORTED FROM THIS BATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129594 RELI ANESTHESIA NEEDLE BSP DR, JAPAN CO., LTD. 23150-5

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Unknown Disability| H