Ref: (b)(4).Investigation: x-initiated manufacturer's investigation.X-review dhr.X-inspect returned samples.Analysis and findings: a review of the 2 year complaint history for the transwarmer inf,box of 6, part: 20421 shows some similar complaints on file.The transwarmer is a purchased product.The expiration date on the returned product is identified to be 2020-12.Refer to attached images of the returned product.The returned product was sent back to the vendor for further analysis.A review of the incoming inspection records for the transwarmer inf for lot ik178 shows the products were to specification upon receipt.The complaint condition was assessed by vendor.As per the vendor assessment, pouch was received with obvious leak, inspection by the vendor revealed a tear is located on right side of pouch at the midpoint.The seal is intact, the tear is a full separation of the pouch material just above the seal.Root cause of the issue was ascertained to be incorrect handling because this kind of damage requires significant force such as dropping the case, etc.Correction and/or corrective action: none.No changes to the process or procedure.Was the complaint confirmed? yes.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.
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