MISI: MEDICAL IMAGING SOLUTIONS INTL.

Description of Event or Problem

WHILE ATTEMPTING TO INJECT CONTRAST WITH POWER INJECTOR FOR A CTA [COMPUTED TOMOGRAPHY ANGIOGRAPHY] STUDY, I HEARD A LOUD POP AND NOTICED THE CONTRAST SYRINGE MOVING WITH THE PLUNGER. I STOPPED THE INJECTOR, REMOVED THE BROKEN SYRINGE. I REPLACED THE SYRINGE AND CONTRAST AND COMPLETED EXAM WITHOUT ANY FURTHER ISSUES 2ND MALFUNCTION OF CT SYRINGE FROM SAME LOT # 2410174 OF THE PREVIOUS ISSUE. FRACTURE OF DEVICE AT BOTTOM OF PLUNGER. TECHNOLOGIST REPORTED AND FOLLOWED UP WITH VENDOR REGARDING THE SECOND INCIDENT WITHIN A SHORT TIME SPAN. DISCUSSED WITH REP: [REDACTED]. [REDACTED] ¿ EXPEDITE OPEN ORDER (SEE BELOW) OF PN 400109 WITH NEW LOT NUMBER. [REDACTED], IMAGING DIRECTOR - CHECK WITH RECEIVING ON INVENTORY CASE AND LOT NUMBERS. [REDACTED] ¿ SEND INFORMATION ABOUT SYRINGE WHICH FRACTURED ON [REDACTED] MOBILE PHONE [REDACTED]. [REDACTED] ¿ COMPLETE CUSTOMER INTAKE FORM AND CC [REDACTED] FOR USE WITH INCIDENT REPORT. ALL ¿ SITE VISIT MEETING NEXT THURSDAY ON INVESTIGATION FINDINGS AND PRODUCT PERFORMANCE. MANUFACTURER RESPONSE FOR SYRINGE FROM POWER INJECTOR, MISI (PER SITE REPORTER). SITE VISIT MEETING ON [REDACTED].