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Patient 1
(B)(4). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). ALTHOUGH THE BATCH NUMBER OF THE ITEM INVOLVED IN THE REPORTED INCIDENT IS UNKNOWN, TWO POTENTIAL BATCHES WERE REPORTED, 18D18G8301 AND 18D09G8303. A DHR REVIEW WAS PERFORMED FOR EACH OF THE REPORTED BATCHES. DEVICE HISTORY RECORD (DHR): REVIEWED THE DHR, THERE ARE NO ABNORMALITIES FOUND DURING IN PROCESS AND FINAL CONTROL INSPECTION. SAMPLE FOR EVALUATION: RECEIVED 1 USED CONTAMINATED CAPILLARY HUB OF INTROCAN SAFETY-W FEP 20G, 1.1X32MM-AP WITHOUT PACKAGING. ATTACHED WITH THE RETURNED SAMPLE WAS A LUER CONNECTOR, PRESUMABLY THE CUSTOMER USED WITH THE INTROCAN SAFETY. THE CANNULA HUB AND PROTECTIVE CAP WERE NOT RETURNED FOR INVESTIGATION. INVESTIGATION RESULTS: VISUAL INSPECTION OBSERVED THE CAPILLARY WAS TORN OFF APPROXIMATELY 7MM FROM THE CAPILLARY HUB HORN. TORN OFF PIECE OF THE CAPILLARY WAS NOT RETURNED FOR INVESTIGATION. THE TORN AREA HAD AN UNEVEN SHAPE LIKE IT HAS BEEN CLAMPED. THE ROOT CAUSE POTENTIALLY DUE TO APPLICATION FAULT. COMPLAINT IS NOT CONFIRMED. NOTE: THIS REPORT IS BEING FILED AS BOTH A PRODUCT PROBLEM AND AN ADVERSE EVENT DUE TO THE FACT THAT THE TIP OF THE CATHETER MAY HAVE REMAINED IN THE PATIENT. NO INTERVENTION WAS DONE, AND CURRENTLY THERE IS NO SERIOUS INJURY TO THE PATIENT, SO THIS REPORT HAS BEEN CLASSIFIED ONLY AS A MALFUNCTION.