PERIFIX®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: CATHETER WAS TORN/FRAYED WHEN THE PATIENT WAS TURNED OVER BY THE FAMILY MEMBER BY TUGGING ON THE GOWN, THIS HAPPENED RIGHT ABOVE WHERE IT WAS TAPPED TO THE BACK OF THE PATIENT. THE REMAINDER OF THE CATHETER WAS REMOVED INTACT WITHOUT ANY HARM TO THE PATIENT. ANESTHESIA DID NOT FEEL AN X-RAY WAS NEEDED AT THIS TIME.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THREE USED SAMPLES INVOLVED IN THE REPORTED INCIDENT WERE PROVIDED. WHEN THE UNITS WERE EVALUATED, TWO OF THE THREE SAMPLES WERE NOTED TO BE DAMAGED WITH THE COIL STRETCHED OUT AND THE TIP SHEARED OFF. ALTHOUGH THE RETURNED SAMPLES SHOWED THE TIP TO BE SHEARED OFF, SINCE ALL CATHETERS HAD BEEN OPENED AND SEVERELY DAMAGED DURING USE, IT WAS UNABLE TO BE CONFIRMED TO BE THE RESULT OF ANY MANUFACTURING PROCESS. FIVE UNOPENED KITS IDENTIFYING THE REPORTED LOT NUMBER WERE RETURNED FOR EVALUATION. UPON INVESTIGATION, VISUAL EVALUATION REVEALED NO DAMAGE OR DEFECTS. THE CONNECTORS WERE ATTACHED TO THE CATHETERS AND PULL TESTED WITH PASSING RESULTS. THE REPORTED CONCERN WAS UNABLE TO BE REPLICATED OR CONFIRMED. A REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.