Catalog Number 309620 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/30/2019 |
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.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that 5 syringe catheter tip 2oz experienced incorrect label information which was noted prior to use.The following information was provided by the initial reporter: material no: 309620 batch no: unknown.Reported issue: box is labeled as 60ml not 50ml.
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Event Description
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It was reported that 5 syringe catheter tip 2oz experienced incorrect label information which was noted prior to use.The following information was provided by the initial reporter: material no: 309620 batch no: unknown reported issue: box is labeled as 60ml not 50ml.
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Manufacturer Narrative
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Mfr# 1911916-2019-01207 has been deemed not reportable after further review and will be cancelled.There was no report of serious injury, medical intervention, or reportable device malfunction.General dissatisfaction of the product does not impact the intended use of the device which would not lead to harm or serious injury to the clinician or patient.As a result mfr# 1911916-2019-01207 is null and void.
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Search Alerts/Recalls
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