Catalog Number 382806 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the 20g x 1.16in (1.1 x 30 mm) insyte-a experienced missing label information which was noted prior to use.The following information was provided by the initial reporter: after delivery to merit medical from bd, one package with a bar code missing in part was found during visual checking in its plant.
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Manufacturer Narrative
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H.6.Investigation summary: in response to the event reported by your facility a device history review was conducted for lot number 9228774.Our records show that this is the only instance of labeling issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Based on the provided photo our quality engineers were able to determine that the root cause for this event is related to the manual application of the barcode to the product packaging.To address this situation our operators have been retrained on the proper application of the bar code and we have updated our operating procedures in increase inspection intervals during the course of production.H3 other text : see h.10.
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Event Description
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It was reported that the 20g x 1.16in (1.1 x 30 mm) insyte-a experienced missing label information which was noted prior to use.The following information was provided by the initial reporter: after delivery to merit medical from bd, one package with a bar code missing in part was found during visual checking in its plant.
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Search Alerts/Recalls
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