ARROW EPIDURAL CATHETERIZATION KIT NRFIT
Received Jun 11, 2025 · Event occurred May 9, 2025
Report 3006425876-2025-00515 · MDR key 22183550
Device
Generic name
Epidural Anesthesia Kit
Manufacturer
Arrow International LlcCatalog number
OU-05500-NRO
Lot number
71F24D1043
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
Description of Event or Problem
IT WAS REPORTED THAT: "THE GLASS OF THE LOR SYRINGE WAS FOUND BROKEN BEFORE USE. THEREFORE, A NEW KIT WAS USED INSTEAD. THE HEALTHCARE PROVIDER WAS NOT CUT OR INJURED WHEN THE GLASS LOR SYRINGE BROKE PRIOR TO PATIENT USE."
Additional Manufacturer Narrative
QN# (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT: "THE GLASS OF THE LOR SYRINGE WAS FOUND BROKEN BEFORE USE. THEREFORE, A NEW KIT WAS USED INSTEAD. THE HEALTHCARE PROVIDER WAS NOT CUT OR INJURED WHEN THE GLASS LOR SYRINGE BROKE PRIOR TO PATIENT USE."