POSIFLUSH- SP

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

A NURSE NOTICED THAT A POSIFLUSH NACL 0.9% 5 ML SYRINGE CONTAINED ONLY 4 ML AFTER BEING PURGED OF AIR. WHEN DID THE INCIDENT OCCUR? = DURING USE ADDITIONAL INFORMATION 06-NOVEMBER-2025: A NUMBER OF ADDITIONAL QUESTIONS FROM OUR SIDE TO MAKE THE FURTHER INVESTIGATION RUN MORE SMOOTHLY: HAS ANYTHING VISUALLY STOOD OUT ABOUT THE SYRINGE? FOR EXAMPLE, DAMAGE, LEAKAGE, DEVIATIONS IN THE PACKAGING? NO WAS THE SYRINGE CORRECTLY VENTED ACCORDING TO THE INSTRUCTIONS FOR USE (SEE ATTACHMENT)? CAN THE NURSE DESCRIBE THE EXACT VENTING PROCESS? THE NURSE BLEED THE SYRINGE CORRECTLY (AN ACTION SHE DOES SEVERAL TIMES A DAY). WAS THE VOLUME MEASURED BEFORE OR AFTER VENTING? HOW WAS THE VOLUME MEASURED? IN THE SYRINGE ITSELF AND AFTER VENTING IT WAS DETERMINED THAT THERE WAS ONLY 4 ML IN THE SYRINGE . WERE OTHER SYRINGES FROM THE SAME LOT NUMBER USED AND IF SO, DID THEY SHOW THE SAME DEVIATION? HEARD SEVERAL TIMES BUT NOT SENT IT BECAUSE IT HAD ALREADY BEEN REPORTED. IS THERE A PATTERN IN THE ABNORMALITY? FOR EXAMPLE: DOES THE PROBLEM ONLY OCCUR AT A CERTAIN TIME, DEPARTMENT, OR USER? NO HOW AND WHERE WAS THE PRODUCT STORED BEFORE USE? WERE THE STORAGE CONDITIONS (TEMPERATURE, HUMIDITY, ETC.) RESPECTED? VANAS CABINET. WAS ANYTHING UNUSUAL NOTICED WHEN OPENING THE PACKAGE? FOR EXAMPLE, AIR BUBBLES, LEAKAGE, OR AN ABNORMAL SMELL? LARGE BUBBLE. WHAT TYPE OF PATIENT OR PROCEDURE WAS THE SYRINGE USED FOR? WAS THERE A SPECIFIC NEED FOR EXACTLY 5 ML? SO FOR RINSING AFTER ANTIBIOTICS YOU DON'T NECESSARILY NEED 5 CC.

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306574 AND LOT NUMBER 3312651. THE REVIEW CONFIRMED THAT THE LOT WAS RELEASED ACCORDING TO DEFINED SPECIFICATIONS AND REQUIREMENTS INCLUDING STERILIZATION AND FINAL LAB TESTING. THERE WERE NO NON-CONFORMANCES OR ISSUES ASSOCIATED WITH THE REPORTED DEFECT. THERE WAS NO DOCUMENTATION OF ANY ISSUE AFFECTING THE FILLING PROCESS WHICH COULD BE RELATED TO THE REPORTED ISSUE. ALL INSPECTIONS PERFORMED FROM FILLING TO CASE PACKAGING WERE FOUND TO BE ACCEPTABLE. TO AID IN THE INVESTIGATION OF THIS ISSUE, THE PHYSICAL SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SYRINGE SHOWED 3ML OF SOLUTION, IT APPEARED TO BE USED WITH NO UNIT PACKAGING PROVIDED. THE CUSTOMER FEEDBACK STATED THE SYRINGE HAD 4ML, BUT UPON ANALYSIS, THE SYRINGE HAD 3ML. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS REPORTED INCIDENT. IT IS POSSIBLE THAT A FAILURE IN THE REJECTION STATION OCCURRED AFTER A SHORT STOPPAGE DURING MANUFACTURING; HOWEVER, THIS COULD NOT BE CONFIRMED. THIS IS A VERY UNUSUAL CIRCUMSTANCE. BARREL VOLUME IS INSPECTED IN THE FILLING AREA AND IN THE PACKAGING PROCESS. THE FILLING STATION HAS A SENSOR FOR DETECTING FILL ISSUES AND ALSO A REJECTION MECHANISM FOR SHORT STOPPAGES. NO ISSUES WERE DETECTED DURING THE MANUFACTURING PROCESS FOR THIS LOT. THIS IS THE FIRST AND ONLY REPORT RECEIVED FOR THIS TYPE OF ISSUE ON LOT 3312651 AT THIS TIME. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THE PROBABILITY OF THIS DEFECT IS VERY LOW WITH AN UNLIKELY CHANCE OF RECURRENCE. 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.

Description of Event or Problem

NO ADDITIONAL INFORMATION.