INTERA REFILL KIT

Additional Manufacturer Narrative

REASON FOR CORRECTION: UPDATED PATIENT INFORMATION (PART A), INVESTIGATION FINDINGS CODE (ANNEX C), DATE RECEIVED BY MANUFACTURER (SECTION G3), COMPONENT CODE (ANNEX G) AND ADDITIONAL MANUFACTURER NARRATIVE (SECTION H11). A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INTERA ONCOLOGY TESTED THE RETAIN SAMPLES FROM THE SAME LOT/BATCH. DURING THE TESTING, THE OPERATOR INVERTED THE SYRINGE BARREL FOR 60 SECONDS PER SPECIFICATION AND NO LEAKAGE WAS OBSERVED. HOWEVER, THE LIKELY ROOT CAUSE OF THE LEAK IS USE ERROR AS THE CLINIC IS KNOWN NOT TO BE DISCARDING THE SYRINGE BARREL QUICKLY AFTER USE. THE INTERA 3000 HAI PUMP INSTRUCTIONS FOR USE MENTIONS THAT DURING REFILL PROCEDURE WHEN THE OPERATOR ALLOWS THE PUMP TO EMPTY INTO THE SYRINGE BARREL, THE OPERATOR NEEDS TO CLOSE THE STOPCOCK AND DISCONNECT BOTH THE STOPCOCK AND SYRINGE BARREL. AFTER THAT, THE SYRINGE BARREL NEEDS TO BE DISCARDED.

Description of Event or Problem

A CLINIC REPORTED TO INTERA ONCOLOGY OF HAVING ISSUES WITH THE SYRINGE BARREL LEAKING THROUGH THE TYVEK LID. IN ONE INSTANCE, THE SYRINGE BARREL LEAKED CHEMO ONTO THE PATIENT AND BED DURING A ROUTINE REFILL. DURING COMMUNICATION WITH THE CLINIC, IT WAS MENTIONED THAT THIS HAS BEEN A RECURRING ISSUE. THE DEVICE WAS DISCARDED, AND NO PHOTO OR VIDEO EVIDENCE OF THE LEAK IS AVAILABLE. THE CLINIC MENTIONED THEY LEFT THE SYRINGE BARREL INVERTED ON THE TABLE. IN ADDITION, IT WAS CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE AN ADVERSE REACTION.

Description of Event or Problem

A CLINIC REPORTED TO INTERA ONCOLOGY OF HAVING ISSUES WITH THE SYRINGE BARREL LEAKING THROUGH THE TYVEK LID. IN ONE INSTANCE, THE SYRINGE BARREL LEAKED CHEMO ONTO THE PATIENT AND BED DURING A ROUTINE REFILL. DURING COMMUNICATION WITH THE CLINIC, IT WAS MENTIONED THAT THIS HAS BEEN A RECURRING ISSUE. THE DEVICE WAS DISCARDED, AND NO PHOTO OR VIDEO EVIDENCE OF THE LEAK IS AVAILABLE. THE CLINIC MENTIONED THEY LEFT THE SYRINGE BARREL INVERTED ON THE TABLE. IN ADDITION, IT WAS CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE AN ADVERSE REACTION.

Additional Manufacturer Narrative

REASON FOR CORRECTION: UPDATED PATIENT INFORMATION (PART A), INVESTIGATION FINDINGS CODE (ANNEX C), COMPONENT CODE (ANNEX G) AND ADDITIONAL MANUFACTURER NARRATIVE (SECTION H11). A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INTERA ONCOLOGY TESTED THE RETAIN SAMPLES FROM THE SAME LOT/BATCH. DURING THE TESTING, THE OPERATOR INVERTED THE SYRINGE BARREL FOR 60 SECONDS PER SPECIFICATION AND NO LEAKAGE WAS OBSERVED. HOWEVER, THE LIKELY ROOT CAUSE OF THE LEAK IS USE ERROR AS THE CLINIC IS KNOWN NOT TO BE DISCARDING THE SYRINGE BARREL QUICKLY AFTER USE. THE INTERA 3000 HAI PUMP INSTRUCTIONS FOR USE MENTIONS THAT DURING REFILL PROCEDURE WHEN THE OPERATOR ALLOWS THE PUMP TO EMPTY INTO THE SYRINGE BARREL, THE OPERATOR NEEDS TO CLOSE THE STOPCOCK AND DISCONNECT BOTH THE STOPCOCK AND SYRINGE BARREL. AFTER THAT, THE SYRINGE BARREL NEEDS TO BE DISCARDED.

Additional Manufacturer Narrative

A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. AS PREVIOUSLY MENTIONED, IN OUR COMMUNICATION WITH THE CLINIC, THEY MENTIONED LEAVING THE SYRINGE BARREL INVERTED ON THE TABLE. INTERA ONCOLOGY TESTED THE RETAIN SAMPLES FROM THE SAME LOT/BATCH. DURING THE TESTING, THE OPERATOR INVERTED THE SYRINGE BARREL FOR 60 SECONDS PER SPECIFICATION AND NO LEAKAGE WAS OBSERVED. THEREFORE, THE ROOT CAUSE OF THE LEAK IS USE ERROR AS THE CLINIC MOST LIKELY LEFT THE DEVICE INVERTED FOR MORE THAN 60 SECONDS. THIS SYRINGE BARREL IS ONLY INTENDED TO STAY INVERTED FOR 60 SECONDS. INTERA ONCOLOGY REQUESTED THE CLINIC FOR THE REQUIRED PATIENT INFORMATION AND TO DATE THE INFORMATION HAS NOT BEEN PROVIDED.

Description of Event or Problem

A CLINIC REPORTED TO INTERA ONCOLOGY OF HAVING ISSUES WITH THE SYRINGE BARREL LEAKING THROUGH THE TYVEK LID. IN ONE INSTANCE, THE SYRINGE BARREL LEAKED CHEMO ONTO THE PATIENT AND BED DURING A ROUTINE REFILL. DURING COMMUNICATION WITH THE CLINIC, IT WAS MENTIONED THAT THIS HAS BEEN A RECURRING ISSUE. THE DEVICE WAS DISCARDED, AND NO PHOTO OR VIDEO EVIDENCE OF THE LEAK IS AVAILABLE. THE CLINIC MENTIONED THEY LEFT THE SYRINGE BARREL INVERTED ON THE TABLE. IN ADDITION, IT WAS CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE AN ADVERSE REACTION.