RELI
Received Jul 16, 2025
Report 1058382-2025-00002 · MDR key 22518793
Device
Generic name
Anesthesia Needle
Manufacturer
Dr, Japan Co., Ltd.Catalog number
SN22G151-RW
Lot number
23150-5
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
7 YR · Unknown
- Headache
- Headache
Narrative
Description of Event or Problem
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
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.