UMBILICAL CATHETER
Received Apr 25, 2023 · Event occurred Mar 14, 2023
Report 2245270-2023-00025 · MDR key 16807830
Product problems
- Material Puncture/Hole
- Material Puncture/Hole
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WE HAD AN ISSUE ON ONE OF THE UVC CATHETERS WE USE, PRODUCT NUMBER 1274.17, WHERE A HOLE WAS FOUND IN THE LINE. NOTE FROM CLINICAL BELOW: NOTED HOLE IN PATIENT'S UVC LINE WHEN REMOVED (HOLE WOULD BE AT OR BELOW THE 5 CM MARKING). 24G UVC. THERE WAS NO PATIENT HARM NOTED IN THIS EVENT, AND THEY DID NOT NOTE A LOT NUMBER FOR THIS UVC.
Additional Manufacturer Narrative
THIS MDR WAS INITIALLY SENT UNDER NUMBER 2245270-2023-00025 ON APRIL 24, 2023. THESE REPORTS REQUIRE A CORRECTION. CORRECTION: THE PRODUCT CODE ASSOCIATED WITH THE COMPLAINT SHOULD BE 1274.14. THE PREVIOUS REPORT LISTED 274.17, ERRONEOUSLY. THE COMPLAINT AND RETURNED SAMPLE WERE SUBMITTED TO THE MANUFACTURER, VYGON FRANCE, FOR EVALUATION. THE FOLLOWING IS A SUMMARY OF THEIR INVESTIGATION: WE RECEIVED A SAMPLE FOR INVESTIGATION, BUT THE CUSTOMER SENT US CODE 1274.14 INSTEAD OF 1274.17. CODE 1274.17 HAS A GREEN TIP, WHEREAS THE SAMPLE RECEIVED DOES NOT, AND THE OUTSIDE DIAMETER AND THE LENGTH OF THE TUBE CORRESPONDS TO CODE 1274.14 (1.50 NOT 1.70). VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED NO ANOMALIES. FUNCTIONAL ANALYSIS ALSO SHOWED THAT THERE WAS NO LEAKAGE IN THE SAMPLE, NO LEAKAGE IN THE ENTIRE TUBE, AND NO LEAKAGE IN THE LINES. THERE IS ALSO NO HOLE NEAR THE 5 CM MARK AS INDICATED BY THE CUSTOMER. THE DRILLING, THE BLUNT END, AND THE MARKING COMPLY WITH THE SPECIFICATIONS. THIS COMPLAINT COULD NOT BE CONFIRMED WE COULD NOT CHECK THE BATCH RECORDS AS NO BATCH NUMBER WAS PROVIDED. OUR CATHETERS ARE 100% LEAK TESTED AT A PRESSURE OF 1 BAR DURING THE PRODUCTION. WE HAVE NOT RECORDED ANY SIMILAR COMPLAINTS (TUBE PERFORATION) ON CODES 1274. XX. CORRECTIVE ACTION: BASED ON VYGON FRANCE INVESTIGATION, NO DEFECTS WERE FOUND IN THE RETURNED SAMPLE, THEREFORE, NO FURTHER CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME.
Description of Event or Problem
NOTED HOLE IN PATIENT'S UVC LINE WHEN REMOVED (HOLE WOULD BE AT OR BELOW THE 5 CM MARKING). 24G UVC.
Additional Manufacturer Narrative
THE MALFUNCTIONING DEVICE WILL BE RETURNED TO VYGON FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE PENDING AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION VIA FOLLOW UP MDR.