ENEMA ADM UNIT -BAG /SOAP/PAD

Additional Manufacturer Narrative

NO SAMPLE WAS RECEIVED FOR EVAL; THEREFORE, WE ARE UNABLE TO CONFIRM THE ISSUE REPORTED. THE PVC TUBING IS DESIGNED AND VALIDATED FOR PT USE. THE CURRENT RIGIDITY OF PVC TUBING AND SHAPE, FACILITATES THE ENEMA ADMINISTRATION UNDER SUPERVISION OF MEDICAL STAFF. THE DEVICE MASTER RECORD AND DEVICE HISTORY RECORDS FOR THE LOTS REPORTED INDICATE THAT THE COMPLETE MFG PROCESSES AND INSPECTIONS SHOWED NO ISSUES. THE EQUIPMENT, PROCESSES AND PARTS USED IN THE MFR OF THIS PRODUCT WERE VERIFIED AND CONFORM TO THE PRODUCT SPECIFICATIONS. BASED ON THE INFO THAT HAS BEEN REVIEWED THERE IS NO INDICATION OF ANY PRODUCT FAILURE, THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

Description of Event or Problem

RECTAL PERFORATION FOLLOWED WITH LIQUID EXTRAVASATION PERITONEAL OF THE PT. PROBE TIP COULD HAVE BEEN DEFECTIVE CAUSING THE PERFORATION.