EPIDURAL CATHETERIZATION KIT NRFIT

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER REPORTED RESISTANCE WAS FELT WHEN SLIDING THE PLUNGER OF THE LOR SYRINGE. THE CUSTOMER RETURNED ONE EMPTY LOT WITH ONE GLASS 5ML LOR SYRINGE NRFIT. THE RETURNED LOR SYRINGE WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED SYRINGE APPEARS TYPICAL; HOWEVER, MICROSCOPIC EXAMINATION REVEALED A DRIED RESIDUE COULD BE SEEN ON THE PLUNGER TIP AND INSIDE THE BARREL. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. PRIOR TO DECONTAMINATION, AN ATTEMPT WAS MADE TO SLIDE THE SYRINGE PLUNGER INSIDE THE BARREL. THE RETURNED SYRINGE PLUNGER WOULD NOT SLIDE AS THE PLUNGER'S TIP APPEARED TO BE STUCK AT THE TOP OF THE BARREL. AFTER DECONTAMINATION OF THE RETURNED SYRINGE, AN ATTEMPT ONCE AGAIN TO SLIDE THE SYRINGE PLUNGER INSIDE THE BARREL WAS PER-FORMED. THE SYRINGE PLUNGER WILL SLIDE IN AND OUT OF THE BARREL WITH LITTLE RESISTANCE MET. THE MOVEMENT IN THE SYRINGE BARREL FEELS TYPICAL. THE RETURNED SYRINGE WAS FUNCTIONALLY TESTED, PLUNGER MOVEMENT TEST. A NEOPRENE SLEEVE WAS PLACED ON THE PLUNGER TO PREVENT BREAKAGE, AND THE PLUNGER WAS RETRACTED OUT OF THE BARREL TO THE 5ML MARKER. THE PLUNGER WAS THEN RELEASED. THE PLUNGER FELL FREELY TO THE BOTTOM OF THE SYRINGE BARREL. THE TEST WAS REPEATED TWICE, ROTATING THE PLUNGER 90 AND 180 DEGREES. THE PLUNGER WAS ABLE TO FREELY FALL EACH TIME. THERE WERE NO FUNCTIONAL ISSUES FOUND AFTER THE RETURNED SYRINGE WAS DECONTAMINATED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE LOR SYRINGE WITH NO RELEVANT FINDINGS. THE REPORTED COMPLAINT OF RESISTANCE BEING FELT WHEN SLIDING THE PLUNGER ON THE LOR SYRINGE WAS CONFIRMED BASED ON THE SAMPLE RECEIVED. VISUAL EXAMINATION OF THE RETURNED SAMPLE REVEALED DRIED RESIDUE COULD BE SEEN ON THE PLUNGER'S TIP AND INSIDE THE BARREL. PRIOR TO DECONTAMINATION, THE PLUNGER'S TIP APPEARED TO BE STUCK AT THE TOP OF THE BARREL. AFTER DECONTAMINATION, THE RETURNED LOR SYRINGE FUNCTIONED AS INTENDED, INCLUDING PASSING A PLUNGER MOVEMENT TEST. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE LOR SYRINGE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. IT IS UNKNOWN HOW THE LOR SYRINGE WAS HANDLED PRIOR TO AND DURING USE. THEREFORE, 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 USER FELT RESISTANCE WHEN SLIDING THE PLUNGER OF LOR SYRINGE DURING A PRETEST BEFORE USE. THEREFORE, A NEW KIT WAS OPENED INSTEAD."

Description of Event or Problem

IT WAS REPORTED THAT: "THE USER FELT RESISTANCE WHEN SLIDING THE PLUNGER OF LOR SYRINGE DURING A PRETEST BEFORE USE. THEREFORE, A NEW KIT WAS OPENED INSTEAD."

Additional Manufacturer Narrative

(B)(4).