UMBILICAL CATHETER DUAL LUMEN 5FR

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. H3: DEVICE EVALUATION COMMENT - THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT HAS BEEN DISCARDED.

Description of Event or Problem

CUSTOMER REPORTS: THE DEVICE WAS FOUND CRACKED WHEN THEY OPENED THE PRODUCT PACKAGING.

Additional Manufacturer Narrative

ACCORDING TO THE SALES REP, IT HAS BEEN CONFIRMED THAT THE INCORRECT PRODUCT CODE WAS INITIALLY REPORTED. BASED ON THE NEW INFORMATION RECEIVED ON 05/15/24, THE FOLLOWING FIELDS HAVE BEEN UPDATED: D1: BRAND NAME - UPDATED FROM UMBILICAL CATHETER DUAL LUMEN 3.5FR TO UMBILICAL CATHETER DUAL LUMEN 5FR. D4: MODEL NUMBER - UPDATED FROM PRODUCT CODE # 8888160531 TO PRODUCT CODE # 8888160556. D4: UNIQUE IDENTIFIER (UDI) # UPDATED FROM (B)(4).

Additional Manufacturer Narrative

BASED ON THE INFORMATION AVAILABLE TO US, WE WERE UNABLE TO CONFIRM THE EVENT, AND DETERMINED THAT: THE DEVICE HISTORY RECORD (DHR) REVIEW OF THE REPORTED LOT NUMBER SHOWS EVIDENCE THAT THE PRODUCT WAS RELEASED ACCORDING TO ALL ESTABLISHED PROCEDURES AND QA DOCUMENTATION. TWO CATHETER SAMPLES WITH NO SIGNS OF USE WERE RECEIVED IN A GENERIC PLASTIC BAG WITHIN THEIR ORIGINAL PACKAGE WITH THE INTACT SEAL. VISUALLY, THERE WERE NO ISSUES DETECTED. ADDITIONALLY, A LEAK TEST WAS PERFORMED UNDER WATER TO EVALUATE THE REPORTED DEFECT AND THE TEST PERFORMED SHOWED THAT THE CATHETER DID NOT LEAK. BASED ON THE INVESTIGATION, IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. A100% IN PROCESS VISUAL INSPECTION IS PERFORMED AT THE PLANT TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. ALL INFORMATION RECEIVED WILL BE USED FOR FURTHER TRACKING AND TRENDING PURPOSES.