ADMINISTRATION SET
Received Aug 22, 2025 · Event occurred Jul 17, 2025
Report 2245270-2025-00101 · MDR key 22876414
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
CORRECTION: THE LOT NUMBER HAS BEEN CORRECTED FROM 120255BA TO 120225BA. THE INITIAL REPORT LISTED IT INCORRECTLY AS 120255BA. THE CUSTOMER DID NOT PROVIDE ANY DEFECTIVE SAMPLES. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, THE CUSTOMER WAS UNABLE TO PROVIDE THE REQUESTED DETAILS. VYGON COLOMBIA TESTED A RETAINED SAMPLE FROM STOCK USING THE UNDERWATER LEAK TEST. NO LEAKS WERE DETECTED, AND THE SAMPLE COMPLIED WITH THE SPECIFICATIONS. AS WE DID NOT RECEIVE DEFECTIVE SAMPLES OR ANY IMAGES SHOWING THE DEFECT, AND THE RETAINED SAMPLE PASSED LEAK AND OCCLUSION TESTING, THE REPORTED CLAIM COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE IDENTIFIED. THE CUSTOMER PROVIDED BATCH NUMBER 120255BA. HOWEVER, UPON INVESTIGATION, WE FOUND THIS BATCH NUMBER TO BE INCORRECT. BASED ON OUR RECORDS, THE CORRECT BATCH NUMBER SHOULD BE 120225BA. WE HAVE REQUESTED VYGON COLOMBIA TO PERFORM A BATCH REVIEW FOR BATCH 120225BA. ACCORDING TO THEIR BATCH REVIEW, NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS. VYGON COLOMBIA PERFORMED VISUAL INSPECTION, SEAL PULL TESTING, AND LEAK AND OCCLUSION TESTING AS PART OF THEIR QUALITY CONTROL PROCESS. A TWO-YEAR REVIEW OF VYGON USA COMPLAINTS DATA REVEALED NO ADDITIONAL REPORTS OF LEAKING RELATED TO AMS-426-1. CORRECTIVE ACTION: THERE IS NO EVIDENCE OF FAILURE TO WARRANT OPENING A CORRECTIVE OR PREVENTIVE ACTION AT THIS TIME. ADDITIONALLY, NO OTHER COMPLAINTS HAVE BEEN RECEIVED TO SUGGEST THIS IS A SYSTEMIC ISSUE. VYGON WILL CONTINUE TO MONITOR THE SITUATION AND ESCALATE AS APPROPRIATE.
Description of Event or Problem
THE CUSTOMER ADVISED THAT THEY HAVE HAD SEVERAL COMPLAINTS FROM THEIR VARIOUS OFFICE LOCATIONS THAT THIS PRODUCT IS LEAKING FLUID WHEN CONNECTED. THEY TRIED DIFFERENT LOT NUMBERS FROM A DIFFERENT BOX AND THEY STILL HAVE ISSUES.
Additional Manufacturer Narrative
THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE REPORTED TO THE FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA A FOLLOW-UP MDR.
Description of Event or Problem
THE CUSTOMER ADVISED THAT THEY HAVE HAD SEVERAL COMPLAINTS FROM THEIR VARIOUS OFFICE LOCATIONS THAT THIS PRODUCT IS LEAKING FLUID WHEN CONNECTED. THEY TRIED DIFFERENT LOT NUMBERS FROM A DIFFERENT BOX AND THEY STILL HAVE ISSUES.