INF SET VERSARATE ADJ FLOW

Description of Event or Problem

DOSE/FREQUENCY/ROUTE: USE AS DIRECTED TO ADMINISTER IG. INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED. PATIENT REPORTS 2 DEFECTIVE VERSARATE ADAPTORS IN THE PAST MONTH. PT STATED BOTH LEAKED WHERE THEY JOIN THE PREFILLED SYRINGE. ONE LEAKED IMMEDIATELY, THE OTHER STARTED LEAKING AFTER ABOUT 5 MINUTES WHEN THEY HEARD A CRACKING NOISE. IN BOTH CASES THEY REPLACED THE ADAPTORS WITH SPARES AND WAS ABLE TO CONTINUE WITH NO TROUBLE. NO OTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY PT/CAREGIVER. REF REPORT: MW5160270.