CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, H6 (UPDATE CODES), H11. B5: UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS REPORTED THAT THE DEVICE HAD A DYNAMIC LEAK. THE ISSUE OCCURRED WHEN THE ANESTHETIST WAS INJECTING INTO THE "Y" SITE, THE DRUG (INDUCTION AGENT) LEAKED AROUND THE SITE. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOGRAPH SHOWED THE SET; HOWEVER, NO LEAK WAS OBSERVED. THE REPORTED CONDITION WAS NOT VERIFIED ON THE PHOTO SAMPLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

D4: UNIQUE IDENTIFIER (UDI) #: THE LOT NUMBER (10) IS UNKNOWN; THEREFORE, THE UDI NUMBER ONLY WILL CONTAIN THE DEVICE IDENTIFIER (01). E1: INITIAL REPORTER ADDRESS: (B)(6). E1: INITIAL REPORTER POSTAL CODE: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A CONTINU-FLO BLOOD/SOLN SET LEAKED FROM THE INJECTION PORT. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.