ARGYLE

Description of Event or Problem

THE CUSTOMER REPORTED THAT WHEN THE UMBILICAL CATHETER WAS FLUSHED, A HOLE AT THE 20CM MARK WAS OBSERVED, SO IT WAS REMOVED. THERE WAS NO PATIENT HARM REPORTED.

Additional Manufacturer Narrative

SECTION B5 (DESCRIBE EVENT OR PROBLEM): THE CUSTOMER HAS ORIGINALLY REPORTED THAT ¿HE WAS ASSISTING A DAD IN REPOSITIONING/TRANSFERRING HIS BABY. AS THE CUSTOMER WAS DOING SO, THE EXTENDED DWELL PERIPHERAL INTRAVENOUS CATHETER (EDPIV) SNAPPED AT A CONNECTION SITE. THE CATHETER REMAINED IN THE BABY AND THE EXTERIOR PORTION OF THE CATHETER REMAINED SECURE UNDER THE DRESSING. THE CUSTOMER WAS ABLE TO REMOVE THE CATHETER COMPLETELY WITHOUT INCIDENCE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE PART OF THE CATHETER THAT SNAPPED (BROKE) WAS AT 8 CM. PER CUSTOMER, THE CATHETER WAS RETRIEVED RIGHT AFTER IT BROKE WITH TWEEZERS. NO SURGERY WAS NECESSARY, AND NOTHING WAS LEFT IN THE BABY. THE PROVIDERS OPTED TO INCREASE FEEDING VOLUME TO AVOID PUTTING IN ANOTHER EXTENDED DWELL¿ AND THE CORRECT EVENT DESCRIPTION SHOULD BE ¿THE CUSTOMER REPORTED THAT WHEN THE UMBILICAL CATHETER WAS FLUSHED, A HOLE AT THE 20CM MARK WAS OBSERVED, SO IT WAS REMOVED. THERE WAS NO PATIENT HARM REPORTED" SECTION D8 / D9 (DEVICE AVAILABLE FOR EVALUATION): ORIGINALLY REPORTED BY THE CUSTOMER AS "YES" AND SHOULD BE "NO" SECTION H6 EVALUATION CODES (HEALTH EFFECT - CLINICAL CODE): ORIGINALLY REPORTED AS 2687 FOREIGN BODY IN PATIENT AND SHOULD BE 4582 NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. SECTION H6 EVALUATION CODES (MEDICAL DEVICE PROBLEM CODE): ORIGINALLY REPORTED AS 1069 BREAK AND SHOULD BE 1250 FLUID LEAK.

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THAT HE WAS ASSISTING A DAD IN REPOSITIONING/TRANSFERRING HIS BABY. AS THE CUSTOMER WAS DOING SO, THE EXTENDED DWELL PERIPHERAL INTRAVENOUS CATHETER (EDPIV) SNAPPED AT A CONNECTION SITE. THE CATHETER REMAINED IN THE BABY AND THE EXTERIOR PORTION OF THE CATHETER REMAINED SECURE UNDER THE DRESSING. THE CUSTOMER WAS ABLE TO REMOVE THE CATHETER COMPLETELY WITHOUT INCIDENCE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE PART OF THE CATHETER THAT SNAPPED (BROKE) WAS AT 8 CM. PER CUSTOMER, THE CATHETER WAS RETRIEVED RIGHT AFTER IT BROKE WITH TWEEZERS. NO SURGERY WAS NECESSARY, AND NOTHING WAS LEFT IN THE BABY. THE PROVIDERS OPTED TO INCREASE FEEDING VOLUME TO AVOID PUTTING IN ANOTHER EXTENDED DWELL.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) FOR LOT 2409600118 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. A SAMPLE WAS NOT RECEIVED FOR THE INVESTIGATION. 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. AT THIS TIME, A CORRECTIVE AND PREVENTIVE ACTION IS NOT DEEMED NECESSARY. WE WILL KEEP MONITORING THE PROCESS FOR ANY ADVERSE TRENDS THAT REQUIRE IMMEDIATE ATTENTION. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES.