IT WAS REPORTED THAT THE DRAIN BROKE OFF IN THE PT. A GASTRECTOMY PROCEDURE WAS PERFORMED ON THE PT IN 2009, REMOVAL OF DRAIN WAS PERFORMED TWO DAYS LATER. THE PT CAME BACK FOR A FOLLOW UP X-RAY APPOINTMENT FOUR MONTHS LATER. THE X-RAY SHOWED A PORTION OF THE DRAIN WAS STILL PRESENT IN THE PT'S ABDOMEN. THE RETAINED PORTION OF THE DRAIN SEGMENT WAS LAPAROSCOPICALLY REMOVED THE FOLLOWING MONTH. THE USER FACILITY REPORTED THAT THE DRAIN BREAKAGE AREA WAS NOTED TO BE A CLEAN ANGLE AND THE RETAINED PIECE MEASURED 8.1" IN LENGTH. NO FURTHER COMPLICATIONS WERE REPORTED AND PT IS CURRENTLY DOING FINE.
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Patient 1
NO SAMPLE WAS RETURNED FOR EVAL. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THE LOT NUMBER PROVIDED. THERE WERE NO NON-CONFORMANCES NOTED IN THE DHR THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. INTERNAL REJECTS RECORDS FOR THE PAST 24 MONTHS WERE REVIEWED AND THOSE RECORDS DID NOT SHOW ANY REJECTS RELATED TO TENSILE VALUES. ALL VALUES WITHIN THE LAST TWO YEARS WERE ABOVE THOSE SPECIFIED IN THE INTERNATIONAL STANDARDS FOR SURGICAL DRAINS. AS A FINISHED GOOD, QA PERFORMS VISUAL INSPECTIONS FOR CUTS OR TEARS ON THE SURFACE OF THE DRAIN. ADDITIONALLY, THERE WAS A BREAK STRENGTH TEST (TENSILE TEST) PERFORMED ON THE FINISHED LOT, ALL SPECIFICATIONS WERE MET. THERE WAS NO EVIDENCE OF ANY MANUFACTURING ISSUES THAT MAY CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING PRECAUTIONS TO AVOID THE POSSIBILITY OF DRAIN DAMAGE OR BREAKAGE: "ADDITIONAL PERFORATIONS SHOULD NOT BE MADE IN THE DRAINS. AVOID SUTURING THROUGH DRAINS. DRAINS SHOULD LIE FLAT AND IN LINE WITH THE SKIN EXIT AREAS. PARTICULAR CARE SHOULD BE TAKEN TO AVOID ANY OBSTACLES TO THE DRAIN EXIT PATH. DRAINS SHOULD BE CHECKED FOR FREE MOTION DURING CLOSURE TO MINIMIZE THE POSSIBILITY OF BREAKAGE. DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. DRAINS SHOULD NOT BE HANDLED WITH POINTED, TOOTHED OR SHARP INSTRUMENTS WHICH COULD CAUSE CUTS OR NICKS AND LEAD TO SUBSEQUENT STRUCTURAL FAILURE OF THE DRAIN. SURGICAL REMOVAL MAY BE NECESSARY IF DRAIN IS DIFFICULT TO REMOVE OR BREAKS".