POSIFLUSH XS/SF

Additional Manufacturer Narrative

H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

Description of Event or Problem

BRIEF DESCRIPTION OF THE PROBLEM: DURING DIALYSIS CATHETER IRRIGATION, THE PLUNGER MOVES AND BLOOD BACKFLOW IS OBSERVED AT THE TIP. THE RUBBER SEEMS VERY SOFT, AND THE SYRINGE TIP ALSO UNSCREWS. IMPACT: NURSES OBSERVE THE PRESENCE OF BLOOD IN THE SYRINGE AND ARE CONCERNED THAT IF BLOOD CAN COME OUT, AIR COULD ALSO ENTER. THEY ALSO MENTION THAT THEY CAN GET BLOOD ON THEMSELVES DURING HANDLING. ADDITIONAL INFORMATION 14-NOVEMBER-2025: THE CONSEQUENCE FOR PATIENTS IS THAT WE HAVE TO REDO THE SAMPLES. ON THE OTHER HAND, IT IS MAINLY THE NURSES WHO SUFFER THE CONSEQUENCES, SINCE ON A FEW OCCASIONS THEY HAVE BEEN SPRAYED WITH BLOOD.

Description of Event or Problem

22-DECEMBER-2025: 1. DID THE NURSES WEAR APPROPRIATE PROTECTIVE EQUIPMENT SUCH AS GLOVES? YES, GLOVES AND MASK 2. WAS THERE EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS? NO 3. WAS THERE A NEED FOR DIAGNOSIS OR MEDICAL TREATMENT? 1. IF YES, PLEASE DESCRIBE IN DETAIL. YES, PATIENTS HAVE BIWEEKLY LABS. 4. IT SAYS THAT "FREQUENCY: FREQUENT". 1. WAS THERE MORE THAN ONE OCCURRENCE? 2. IF YES, PLEASE PROVIDE THE DATES OF THE EVENT AND ANY OTHER UNIQUE DETAILS. 3. PLEASE CONFIRM THE NUMBER OF OCCURRENCES. I DON¿T HAVE THE EXACT NUMBER OR DATES, SINCE IT WAS DURING A MEETING DISCUSSION THAT THE GIRLS COMPLAINED THAT THIS HAD HAPPENED, AND SEVERAL MENTIONED THAT IT HAD ALSO HAPPENED TO THEM. EVERYONE THOUGHT IT WAS AN ISOLATED CASE.

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306572 AND LOT NUMBER 5149639. THE REVIEW DID NOT REVEAL ANY POSSIBLE NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, FIVE (5) SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES WERE WITHIN THEIR ORIGINAL BLISTER PACKAGING AND HAD NOT BEEN USED. THE SAMPLES WERE CHECKED FOR DAMAGE TO THE PLUNGER ROD, BARREL, TIP CAP AND LUER AND NO SIGNS OF DAMAGE OR ANY ISSUES WERE IDENTIFIED. AS THE DEFECTIVE SAMPLE WAS NOT RETURNED AND NO PHOTOGRAPHS WERE PROVIDED, AN EXACT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. FOLLOWING OUR INVESTIGATION AND BASED ON THE CUSTOMER VERBATIM IT IS PROBABLE THAT THE REPORTED INCIDENT RESULTED FROM CUSTOMER MISUSE. POSIFLUSH SYRINGES ARE PRE-FILLED SINGLE USE SYRINGES, INTENDED FOR FLUSHING. PREFILLED AND CONVENTIONAL SYRINGES HAVE DIFFERENT PURPOSES. BASED ON THE INVESTIGATION, THE CONCLUSIVE ROOT CAUSE OF THIS COMPLAINT IS UNASSIGNABLE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.