ARROW EPIDURAL CATHETERIZATION KIT NRFIT

Additional Manufacturer Narrative

QN# (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT: "THE GLASS LOR SYRINGE WAS FOUND BROKEN UPON OPENING THE PACKAGE. THEREFORE, A NEW KIT WAS USED INSTEAD."

Additional Manufacturer Narrative

QN(B)(4). THE REPORTED COMPLAINT OF THE LOR SYRINGE BEING BROKEN WAS CONFIRMED BASED ON THE SAMPLE RECEIVED. THE CUSTOMER RETURNED ONE 5ML GLASS LOR SYRINGE NRFIT AND LIDSTOCK. VISUAL EXAMINATION OF THE RETURNED SAMPLE REVEALED THE LOR SYRINGE APPEARED TO BE CRACKED ON THE SHOULDER OF THE BARREL. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL KIT AND THE LOR SYRINGE WITH NO RELEVANT FINDINGS. SINCE IT CANNOT BE DETERMINED WHEN THE SYRINGE BECAME DAMAGED, THE POTENTIAL CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT: "THE GLASS LOR SYRINGE WAS FOUND BROKEN UPON OPENING THE PACKAGE. THEREFORE, A NEW KIT WAS USED INSTEAD."