POSIFLUSH

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: (H) ATTACHED MEDSUN INVESTIGATION RESULTS: AFTER DHR RECORD REVIEW FOR FINAL PRODUCT AND MOULDING BATCHES, IT CAN BE DETERMINED THAT THERE WERE NO ISSUES DOCUMENTED RELATED TO THE REPORTED COMPLAINT. THEREFORE, IT HAS NOT BEEN FOUND ANY SPECIFIC CIRCUMSTANCES, FROM MANUFACTURING PROCESS, THAT COULD EXPLAIN THE DESCRIBED COMPLAINT. SINCE THERE ARE NOT DEFECTIVE SAMPLES AVAILABLE, TWENTY (20) SYRINGES FROM THE RETAINED SAMPLES FROM THE SAME BATCH HAVE BEEN TESTED FOR LEAKAGE (ATT. A). NO LEAKAGE PAST STOPPER NEITHER IN THE SYRINGE TIP HAS BEEN DETECTED. DEFECT CANNOT BE CONFIRMED.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

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

VERBATIM: BEDSIDE REPORT AND IVF [INTRAVENOUS FLUID] RATES BEING VERIFIED. LEAKING FLUID NOTED FROM MEDICATION LINE FILTER THAT IS ATTACHED TO PICC [PERIPHERALLY INSERTED CENTRAL CATHETER]. LIQUID NOTED AT SITE OF FILTER, SOAKED LABEL ON THE LINE AND DROPLETS NOTED ALONG MED LINE. NOTHING INFUSING VIA MED LINE AT THIS TIME. MEDICATION LINE HAD BEEN CHANGED THE PREVIOUS SHIFT. ADDITIONAL INFORMATION 03-NOVEMBER-2025: 1, IN THE MEDSUN FORM, THE DATE OF EVENT IS MENTIONED AS "SEP-2025". CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY? 09/24/2025. 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NA. 3. COULD YOU PLEASE CONFIRM WHERE THE LEAKAGE OCCURED? THE LEAKAGE HAPPENED IN THE POSIFLUSH SYRINGE? NEAR SITE OF FILTER.