SAPPH EPID NV NRFIT MICRO 298CM

Additional Manufacturer Narrative

NO PRODUCT SAMPLES, IMAGES, OR VIDEOS WERE RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORDS (DHR)S FOR THE POSSIBLE LOT NUMBERS WAS REVIEWED AND NO NONCONFORMITIES WERE FOUND WHICH WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE COMPLAINT CANNOT BE CONFIRMED. A BATCH RECORD REVIEW WAS PERFORMED FOR LOT# 916255H AND LOT# 906035H AND NO DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO A COMPLAINT OF THIS NATURE WERE FOUND. THE COMPLAINT CANNOT BE CONFIRMED.

Additional Manufacturer Narrative

THE DEVICE IS AVAILABLE FOR INVESTIGATION. HOWEVER, IT HAS NOT YET BEEN RECEIVED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. THE CUSTOMER IDENTIFIED TWO POSSIBLE LOT NUMBERS: 916255H (EXPIRY DATE 07/01/2021, MFR DATE 07/01/2018) AND 906035H (EXPIRY DATE 06/01/2023, MFR DATE 06/01/2018).

Description of Event or Problem

THE EVENT INVOLVED A SAPPHIRE EPIDURAL NV NRFIT MICRO 298CM THAT THE CUSTOMER REPORTED A CRYSTALIZED OR ABNORMAL PLASTIC THREAD AND ALSO THAT THE FILTER HAD BUBBLES AND CONDENSATION. IT WAS REPORTED THAT THE EPIDURAL INFUSION RATE WAS MOST LIKELY 10MLS/HR (FOR POST-OP ANALGESIA) AND THE MEDICATION INVOLVED WAS PLAIN LEVO OR LEVO & FENT 4MCG MIX. THE DEVICE WAS IN USE WAS FOR AT LEAST SEVERAL HOURS. THERE WAS NO SERIOUS INJURY OR DEATH, NO BLOOD LOSS, NO UNPROTECTED CHEMO EXPOSURE, NO DELAY IN CRITICAL THERAPY, NO ADVERSE OPERATOR CONSEQUENCES AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE DEVICE WAS NOT CHANGED OUT OR REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM. THIS CAPTURES THE FIRST OF TWO EVENTS REPORTED.