3.5FR SINGLE LUMEN POLYURETHANE UMBILICAL CATHETER

Additional Manufacturer Narrative

DEVICE WAS NOT AVAILABLE FOR EXAMINATION. INTERNAL INVESTIGATION INCLUDED REVIEWING THE REPORTED INCIDENT INFORMATION AND CATHETER MATERIAL INSPECTION RECORDS FOR MATERIALS THAT WERE POSSIBLY USED IN THE DEVICE EVENT. THE INVESTIGATION INDICATED NO EVIDENCE OF MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THE EVENT.

Description of Event or Problem

IT WAS REPORTED THAT DURING REMOVAL OF THE UMBILICAL CATHETER FROM THE PATIENT, A 5.5 CM PORTION OF THE CATHETER SEPARATED AND REMAINED IN THE PATIENT. A BEDSIDE SURGERY WAS PERFORMED TO RETRIEVE THE SEPARATED PORTION.

Additional Manufacturer Narrative

INVESTIGATION INCLUDED EVALUATING THE RETURNED DEVICE, WHICH EXHIBITED SIGNS CONSISTENT WITH A BREAK IN THE CATHETER TUBING DUE TO CONTACT WITH A SHARP INSTRUMENT (E.G., SCISSORS). ADDITIONALLY, THE INTERNAL INVESTIGATION INCLUDED REVIEWING THE REPORTED INCIDENT INFORMATION AND CATHETER MATERIAL INSPECTION RECORDS FOR MATERIALS THAT WERE POSSIBLY USED IN THE EVENT DEVICE. THE INVESTIGATION INDICATED NO EVIDENCE OF MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THE EVENT.