After receiving this complaint, we searched for other complaint and we didn't find another complaint on this lot n° for the same issue.
Checking the documentation process revealed that the finished product (b)(4) (lot n°4396949) was made by our (b)(4) subcontractor on jan 2015.
Checking the quality databases revealed no recorded anomaly in connection with the described incident.
We received an opened pouch printed aa6114 lot n°4396949 and 3 sealed folysil catheter with a orange valve printed "15ml-4396949".
The catheter have distal tips with or without silicone burrs, however, the product remains functional.
Based on the above, this complaint is confirmed as a product defect.
No corrective action as the product remains functional.
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