Model Number 381823 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Fda device problem code: 3007, fda patient problem code: 2645.
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Event Description
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It was reported that insyte autoguard bl 22ga x 1.0in cut line is not easy to tear.This occurred on 32 occasions.The following information was provided by the initial reporter: the cutting line is not easy to tear.
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Manufacturer Narrative
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Investigation summary our quality engineer inspected the samples and photographs submitted for evaluation.Bd received thirty-four unused units in sealed packages from material number 381923, lot number 0132284 and two photos.A device history record review showed no non-conformances associated with this issue during the production of this batch.During the visual examination it was observed that the perforated slit between the paired packages was present on the top web but did not go through to the bottom web.The paired packages were attempted to be pulled apart, but they would not easily separate confirming the reported defect.Based on the appearance of the defect, the root cause is likely due to low cutting pressure during the perforation step of the manufacturing process.H3 other text : see h.10.
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Event Description
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It was reported that insyte autoguard bl 22ga x 1.0in cut line is not easy to tear.This occurred on 32 occasions.The following information was provided by the initial reporter: the cutting line is not easy to tear.
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Search Alerts/Recalls
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