(b)(4).Lot 0f04283 was manufactured on 06/28/2020 in the convex one piece manufacturing line, with a total of (b)(4) market units.On 02/jul/2021, a batch record review was performed to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom.No issues related to the defect were found in the documentation.The process carried out was found according to pi21-076.No issues regarding the failure mode reported was found in the documentation.Batch record review supports that no issues regarding the failure mode reported were identified.On 02/jul/2021 a complaint search for lot 0f04283 and malfunction code ost-pmc1.8 / ost-pmc01.08 skin barrier starter hole is defective (e.G.Misalignment or off center), leakage may occur (pre-cut only) was carried out and as a result, no additional complaints were found; therefore, no potential trend is observed.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.
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