UMBILICAL CATHETER SNGL LUMEN 3.5FR

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED A DEFECTIVE ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER. THE CATHETER WAS PLACED ON (B)(6) 2022 AT 6:34PM AND ON (B)(6) 2022 AT 4:04AM THE INFANT BEGAN COUGHING AND THE ADHESIVE DRESSING BECAME LOOSE. UPON REPLACEMENT OF THE DRESSING, THE CATHETER "SNAPPED". THE CATHETER WAS REMOVED BY THE NEONATAL NP AT THE BEDSIDE. THERE WERE NO RETAINED PIECES AND THERE WAS NO HARM TO THE PATIENT. NO CLEANING AGENT CONTAINING ALCOHOL USED. THERE WAS A SWEEP OF THE CLINICAL UNITS AND THE MPSC STOREROOM FOUND ONLY ONE ADDITIONAL PRODUCT WITH THIS LOT NUMBER. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2022, WHEN THE CUSTOMER STATES THE CATHETER "SNAPPED", THEY MEAN THAT THE CATHETER BROKE/SEPARATED.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. TWO CATHETERS WERE RECEIVED FOR THE INVESTIGATION: ONE UNUSED SAMPLE IN A SEALED PACKAGE AND ONE USED SAMPLE. THE UNUSED SAMPLE WAS INSPECTED AND DID NOT SHOW ANY DEFECTS. THE USED SAMPLE WAS INSPECTED AND SHOWED BLOOD RESIDUE AND A BROKEN CATHETER TUBE. THE REPORTED CONDITION WAS CONFIRMED. BASED ON ALL AVAILABLE INFORMATION, IT WAS DETERMINED THAT THE CATHETER WAS IN GOOD CONDITION PRIOR TO USE AS LEAKING WAS NOT DETECTED DURING FLUSHING OR USE OF THE DEVICE AND THE ISSUE WAS ONLY IDENTIFIED AFTER TEN HOURS WHEN REMOVING THE DEVICE FROM THE PATIENT. BASED ON THIS INFORMATION IT COULD BE DETERMINED THAT THAT NOT FOLLOWING THE INSTRUCTIONS FOR USE CORRECTLY COULD CONTRIBUTE TO DAMAGE OF THE CATHETER DURING USE. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.