(b)(4).Date sent to the fda: 4/1/2020.A manufacturing record evaluation was performed for the finished device mic4034; pkbbchq0 number, and no non-conformance's were identified.Investigation summary: it was reported that: clip hold error.The analysis results of the mic4034 cartridge (d) found that it was received empty and six clips loose.No damaged on the cartridge was noted as both the cover and base were observed properly attached.Batch records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Due to condition of the sample, no conclusion could be reached as to what may have caused the reported incident.Investigation summary: it was reported that: clip hold error.The analysis results of the mic4034 reload (e) was received with only one clip loaded with no apparent damaged.The cartridge was tested for functionality with test device.Upon functional testing of the device, the instrument loaded, retained and deployed the clip as intended.The clip was form as intended and conforming to our manufacturing requirements.Batch records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.The clip performed without any difficulties noted.Investigation summary: it was reported that: clip hold error.The analysis results of the mic4034 cartridge (a) found that it was received empty.No damaged on the cartridge was noted as both the cover and base were observed properly attached.Batch records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.It was reported that: clip hold error.The analysis results of the mic4034 cartridge (b) found that it was received empty.No damaged on the cartridge was noted as both the cover and base were observed properly attached.Batch records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.It was reported that: clip hold error.The analysis results of the mic4034 cartridge (c) found that it was received empty.No damaged on the cartridge was noted as both the cover and base were observed properly attached.Batch records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Note: events reported via mw 2210968-2020-02505, 2210968-2020-02506, 2210968-2020-02509, 2210968-2020-02510, 2210968-2020-02511, 2210968-2020-02512.
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