ARGYLE

Description of Event or Problem

CUSTOMER REPORTS: THE SINGLE LUMEN UAV CATHETER WAS FAULTY. A TERM INFANT WITH SEVERE PPHN (PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN) REQUIRING UAC AFTER ADMISSION. THE ASSESSMENT NOTES: APP'S ATTEMPTING TO PLACE 3.5FR UAC. CATHETER WAS FLUSHED WITH HEPARINIZED NORMAL SALINE PRIOR TO INSERTION PER POLICY. CATHETER WAS THEN INSERTED WITH POSITIVE BLOOD RETURN. WHEN ATTEMPTING TO DRAW BLOOD SAMPLES FROM THE LINE, BLOOD WAS ABLE TO BE DRAWN BACK TO THE FUSE AND THEN STOPPED. APP'S WERE UNABLE TO DRAW ANY ADDITIONAL BLOOD BACK OR FLUSH ANY HEP. SALINE FORWARD. THE RECOMMENDATION WAS TO WITHDRAW THE LINE AND A NEW LINE WAS PLACED. THE FAULTY CATHETER WAS LEFT IN THE CARE OF APSM.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. A SAMPLE WAS NOT RECEIVED FOR THE INVESTIGATION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE REPORTED CONDITION AND DETERMINE THE ROOT CAUSE. IF A SAMPLE IS RECEIVED AT A LATER DATE, THE COMPLAINT WILL BE REOPENED, AND THE INVESTIGATION WILL BE UPDATED ACCORDINGLY. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. BASED ON THE INFORMATION AVAILABLE TO US, WE WERE UNABLE TO CONFIRM THE EVENT. IN THE MEANTIME, ALL INFORMATION RECEIVED WILL BE USED FOR FURTHER TRACKING AND TRENDING PURPOSES.