CATHETER, UMBILICAL ARTERY

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THERE WERE NO PHOTOS OR PHYSICAL SAMPLES RECEIVED FOR EVALUATION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE ISSUE AND ROOT CAUSE ANALYSIS. BASED ON THIS INFORMATION, NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME. WE WILL CONTINUE TO TRACK AND TREND THROUGH OUR MONITORING PROGRAMS AND TAKE ACTIONS AS APPLICABLE.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT PLACEMENT OF AN UMBILICAL VEIN CATHETER AND UMBILICAL ARTERY CATHETER. THE UMBILICAL ARTERY CATHETER WAS LEAKING FROM A SMALL CRACK. THE M.D. SEVERED THE UMBILICAL ARTERY CATHETER WHEN ATTEMPTING TO REMOVE SUTURES. PER CUSTOMER, THE PATIENT SUSTAINED SEVERE AND PERMANENT INJURIES THAT REQUIRED ADDITIONAL MEDICAL CARE AND TREATMENT, EXPERIENCED AND WILL CONTINUE TO EXPERIENCE PAIN AND SUFFERING, LOSS OF A NORMAL LIFE, DISABILITY, DISFIGUREMENT, AND INCREASED RISK OF FUTURE HARM, ALL OF WHICH INJURIES ARE PERMANENT IN NATURE.

Additional Manufacturer Narrative

EMDR SECTION H6 (MEDICAL DEVICE PROBLEM CODE) 1135 - CRACK HAS BEEN ADDED AS AN ADDITIONAL DEVICE PROBLEM CODE.