PORTEX TUBES BLUSELECT SUCTIONAID

Additional Manufacturer Narrative

THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER 3011237704-2025-00032-00. THE DATE OF THAT SUBMISSION WAS 25-FEB-2025. INVESTIGATION SUMMARY: ONE USED DECONTAMINATED SAMPLE (B)(6) 7.5MM DEHT BLU SUCTIONAID SUB-ASSY WAS RETURNED FOR INVESTIGATION. CUSTOMER IS CLAIMING THAT THE BLUE SUCTION CONNECTOR IS CRACKED. UNDER VISUAL INSPECTION SUCTION CONNECTOR SEEMS TO BE WITHOUT ANY DEFECT. A LUER SLIP SYRINGE WAS INSERTED INTO THE CONNECTOR AND CRACK WAS OBSERVED. AFFECTED PART 10013213-001 SUCTION LINE SUB-ASSEMBLY BLUSELECT BULK PACKAGED WAS MANUFACTURED BY ICU MEDICAL TIJUANA. THIS DEFECT CAN BE CAUSED BY APPLYING EXCESSIVE FORCE WHEN CONNECTING THE SYRINGE OR DURING THE CONNECTION OF THE SUCTION DEVICE, THE ROOT CAUSE CANNOT BE ASSOCIATED WITH THE MANUFACTURING PROCESS. NO SIGNAL OF CONFIRMED CUSTOMER COMPLAINTS WAS IDENTIFIED IN RELATION WITH THIS ISSUE. A DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS NO LOT NUMBER WAS RECEIVED.

Description of Event or Problem

IT WAS REPORTED THAT THE SUCTION LINE CRACKED DURING USE ON THE PATIENT. SOMEONE BECAME AWARE OF THE ISSUE WHEN STAFF NOTICED PATIENT BLEEDING OUT INTO THE BED. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THE PRODUCT WAS NOT CONTAMINATED NOR CONTAINED A BIOHAZARD OR CHEMOTHERAPEUTIC AGENT. THERE WAS DELAY IN THERAPY, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.