MCKESSON BRANDS

Description of Event or Problem

THE FLEXIBLE CANNULA BECAME LODGED IN THE PATIENT'S ARM. IT APPEARS THAT IT WAS DETACHED FROM ITS HOUSING OR FROM THE PLASTIC THAT SHOULD HAVE HELD IT IN PLACE SO THAT IT COULD BE REMOVED FROM THE PATIENT'S ARM AT THE END OF THE PROCEDURE. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FOR FURTHER TREATMENT AND RETRIEVAL.

Additional Manufacturer Narrative

BATCH MANUFACTURING RECORDS: THE BATCH MANUFACTURING RECORDS (BMR) FOR THE REPORTED BATCH WERE REVIEWED. NO NON-CONFORMITIES RELATED TO THE COMPLAINT WERE OBSERVED IN THE REPORTS. SUPPLIER VERIFICATION: REPORTS WERE VERIFIED FOR ANY SUPPLIER CHANGES OR RAW MATERIAL CHANGES. NO CHANGES WERE INCORPORATED IN THE PROCESS OR MATERIALS. CONTROL SAMPLES: NO NON-CONFORMITIES RELATED TO THE REPORTED COMPLAINT WERE OBSERVED DURING THE VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE CONTROL SAMPLES OF THE SLIDING SAFETY IV CATHETER. THE FOLLOWING TESTS WERE PERFORMED ON THE CONTROL SAMPLES TO INVESTIGATE THE REPORTED COMPLAINT: 1. VISUAL INSPECTION: NO VISUAL DEFECTS WERE OBSERVED IN THE PRODUCT. 2. PULL TEST OF THE CATHETER: OBSERVED WITHIN THE SPECIFICATION. 3. LEAKAGE TEST: NO LEAKAGE OBSERVED IN THE PRODUCT. POSSIBLE ROOT CAUSES PER PRODUCTION TEAM: USER ERROR: THE DEVICE MAY HAVE NOT BEEN USED AS INTENDED BY THE MANUFACTURER THE CATHETER MAY HAVE BEEN DAMAGED OR DEFORMED DUE TO MULTIPLE INSERTION ATTEMPTS BY THE END USER. CONCLUSION: BASED ON THE ROOT CAUSE ANALYSIS AND THE RESULTS OBTAINED FROM THE TESTS CARRIED OUT ON THE CONTROL SAMPLES OF THE REPORTED BATCH, IT IS CONCLUDED THAT THE PRODUCT DOES NOT CONTAIN A MANUFACTURING DEFECT. THE PROBLEM MAY BE RELATED TO THE USER AS THE PRODUCT MEETS THE SPECIFIED REQUIREMENTS WHILE TESTED.