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

CUSTOMER REPORTS: WHEN THE DOCTOR ATTEMPTED TO REMOVE THE CATHETER THAT HAD BEEN PLACED BETWEEN 18 AND 22 HOURS BEFORE (B)(6), IT BROKE, LEAVING THE BABY WITH A PORTION OF THE CATHETER INSIDE THE ARTERY, SO THEY TOOK BABY TO THE OPERATING ROOM TO REMOVE IT. FORTUNATELY, THE SURGEON WAS ABLE TO SEE THE TIP OF THE FRAGMENT AND WAS ABLE TO REMOVE IT WITHOUT PERFORMING A MORE INVASIVE INTERVENTION.

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD (DHR) REVIEW OF THE PRODUCT AND TUBE COMPONENT, THE DOCUMENTED PARAMETERS AND QUALITY TESTS PERFORMED ON THE REPORTED LOT NUMBER SHOW THAT IT WAS MANUFACTURED IN ACCORDANCE WITH THE STANDARDS AND THAT THERE WERE NO DISCREPANCIES THAT COULD BE RELATED TO THE REPORTED EVENT. BASED ON THE REVIEW, IT WAS CONCLUDED THAT THE LOTS WERE RELEASED IN ACCORDANCE WITH PRODUCT REQUIREMENTS. IN ADDITION, THE LOT NUMBERS WERE REVIEWED FOR ASSOCIATED NONCONFORMITY REPORTS (NCR)S, AND IT WAS DETERMINED THAT THERE ARE NO NCRS RELATED TO THESE LOT NUMBERS. A PHYSICAL SAMPLE OF THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION HOWEVER, TWO PHOTOGRAPHS WERE RECEIVED WITH THE REPORTED LOT NUMBER 2132300121 AND PRODUCT CODE 8888160333. A PHOTO EVALUATION IDENTIFIED THAT THE SAMPLE WAS IN ITS ORIGINAL PACKAGE AND THE CATHETER HAS RESIDUES OF BLOOD (SIGNS OF USE) THEREFORE, IT CAN BE CONFIRMED THAT THE CATHETER SHOWED A BREAKAGE IN THE TUBE. THE EVENT REPORTED BY THE CUSTOMER WAS CONFIRMED. BASED ON THE AVAILABLE INFORMATION AND THE RESULTS OF THE PHOTOGRAPH PROVIDED BY THE CUSTOMER AND THE EVENT DESCRIPTION THAT STATES, ¿WHEN THE DOCTOR ATTEMPTED TO REMOVE THE CATHETER THAT HAD BEEN PLACED BETWEEN 18 AND 22 HOURS BEFORE (SEPT 13TH), IT BROKE¿ IT IS DETERMINED THAT THE CATHETER WAS IN GOOD CONDITIONS PRIOR USE. IT CAN BE CONCLUDED THAT PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND THE DEVICE FUNCTIONED AS INTENDED FOR THE REPORTED AN UNDETERMINED TIME; THEREFORE, THE MOST PROBABLE ROOT CAUSE CAN BE CONSIDERED AS UNINTENTIONAL DISPLACEMENT OR MOVEMENT OF THE DEVICE DURING USE CAUSING THE DAMAGE TO THE CATHETER. THE REPORTED COMPLAINT HAS NOT BEEN CONFIRMED AS A MANUFACTURING RELATED ISSUE. NO TRENDS OR TRIGGERS HAVE BEEN FOUND. THEREFORE, A CORRECTIVE OR PREVENTIVE ACTION IS NOT DEEMED NECESSARY AT THIS TIME. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES.

Description of Event or Problem

PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 22, THE AREA WAS COMPLETELY DRIED PRIOR TO INSERTION AND IT WAS NOT DIFFICULT TO INSERT THE DEVICE. EACH LINE WAS FLUSHED ON A REGULAR BASIS USING SALINE SOLUTION WITH A 3CC SYRINGE. THE DEVICE WAS CLEANED WITH CHLOREXIDINE (BACTEREX) WHICH DOES NOT CONTAIN ALCOHOL OR ACETONE. THE TUBING WAS NOT CLEANED BECAUSE IT COMES STERILE. THE PATIENT WAS ADMITTED TO THE OPERATING ROOM BUT THERE WAS NO NEED FOR INTERVENTION BECAUSE THE DOCTOR MANAGED TO REMOVE THE FRAGMENT OF THE CATHETER WITH PLIERS. THE PATIENT DID NOT EXHIBIT ANY SIGNS OR SYMPTOMS OF DISTRESS OR COMPLICATIONS RELATED TO THE EVENT AND THE CURRENT HEALTH STATUS IS GOOD. THERE IS NO FOLLOW UP CARE REQUIRED.

Additional Manufacturer Narrative

A2: ADDED PATIENT AGE A5: ADDED PATIENT WEIGHT B5: DESCRIBE EVENT OR PROBLEM: ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 22 AND WAS ADDED TO THIS FIELD.