ADMINISTRATION SET
Received Sep 19, 2024 · Event occurred Sep 11, 2024
Report 2245270-2024-00078 · MDR key 20258216
Product problems
- Break
- Material Separation
- Break
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
EXTENSION SET IS BREAKING/SEPARATING AT MULTIPLE POINTS ALONG THE SET.
Additional Manufacturer Narrative
THE SAMPLES INVOLVED WERE RECEIVED AND IT WAS OBSERVED THAT THE MLL FITTING HAD FALLEN OFF. THE EXTERNAL DIAMETER OF THE TUBE WITH THE MLL FITTING WERE MEASURED, IT WAS EVIDENT THAT THERE WAS A TRACE OF GLUE, AND THAT THE ASSEMBLY WAS MADE AT THE CORRECT LENGTH DUE TO THE EXISTING MARKING ON THE TUBE. THE MEASUREMENTS OF RETURNED UNUSED DEVICES WERE ALSO CHECKED, AND THE EXTERNAL DIAMETERS OF THE TUBES WERE FOUND TO BE WITHIN SPECIFICATIONS. THEREFORE, VYGON COLOMBIA BELIEVES THAT THE SEPARATION OF THE TUBING IS DUE TO THE TUBING BEING OUT OF TOLERANCE. AS THE LOT NUMBER IS UNKNOWN, THE LOT HISTORY REVIEW COULD NOT BE CONDUCTED. A TWO-YEAR REVIEW OF VYGON USA'S COMPLAINTS DATA FOUND THREE COMPLAINTS RELATED TO LEAKING/TUBING SEPARATION FOR THE AMS-427 PRODUCT, ALL OF WHICH ORIGINATED FROM THIS FACILITY. CORRECTIVE ACTION: BASED ON VYGON COLOMBIA'S INVESTIGATION, THE POSSIBLE CAUSE OF THE TUBING SEPARATION IS RELATED TO THE TUBING ID DIMENSIONS. AS A RESULT, VYGON USA IS CONDUCTING A STUDY TO ASSESS CHANGES IN TUBING DIMENSIONS AND TOLERANCES TO CREATE SUCCESSFUL BOND FOR FLL AND MLL LUERS. REFERENCE (B)(4).
Additional Manufacturer Narrative
THE FAILED DEVICE WILL BE RETURNED TO VYGON FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE REPORTED TO FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR.
Description of Event or Problem
EXTENSION SET IS BREAKING/SEPARATING AT MULTIPLE POINTS ALONG THE SET.