MEDEX MICRO BORE EXTENSION

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO SMITHS MEDICAL. A SAMPLE WAS TEST FOR LEAKAGE BY MANUALLY INTRODUCING WATER USING A SYRINGE. THE SAMPLE PRESENT LEAKAGE BY ONE OF THE SIDE OF THE FILTER. IT WAS OBSERVED THAT THE FILTER IS OPEN IN ONE SIDE WHERE SHOULD BE WELDED. IT PRESENT DAMAGED WHICH MAY INDICATE A WRONG HANDLING OF THE PART. DHR REVIEW WAS EXECUTED AND NO DISCREPANCIES WERE OBSERVED DURING THE MANUFACTURING OF REPORTS LOT 4068818. THE LOT USED OF FILTER P1123-07 WAS 6447/20, NO DEFECTS WERE REPORTED ON THIS LOT OF FILTER. COMPLAINT IS CONFIRMED DUE TO SAMPLE RETURN PRESENT LEAKAGE AT FILTER, HOWEVER ROOT CAUSE IS NOT ATTRIBUTABLE TO MANUFACTURING.

Description of Event or Problem

IT WAS REPORTED THAT THE PICU HAS HAD "7-8+" OCCURRENCES FROM THE SAME LOT, SO 9 FILES CREATED. CRACKED/LEAKING FILTERS WERE REPORTED.NO PATIENT INJURY WAS REPORTED.