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 10/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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 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.: 9240836.Verbatim: customer called and stated they ordered 1 case of the 60 ml bd¿ catheter tip syringe but received a 50 ml syringe, the label on the outside states 60ml.Item 309620 lot 9240836.
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Manufacturer Narrative
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The report mfr# of 1911916-2019-01154 has been deemed not reportable after further review and will be canceled.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# 1911916-2019-01154 is null and void.
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Event Description
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It was reported that the 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.: 9240836.Verbatim: customer called and stated they ordered 1 case of the 60 ml bd¿ catheter tip syringe but received a 50 ml syringe, the label on the outside states 60ml.Item 309620; lot 9240836.
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Search Alerts/Recalls
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