Catalog Number 8065752022 |
Device Problem
Device Slipped (1584)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported when the infusion cannula was inserted into the trocar, it would fall down all the time without being self-standing during a procedure.The procedure was completed while supporting it with his finger until the end (without product replacement).There was no harm to the patient.
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Manufacturer Narrative
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A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.Only the used infusion cannula line was returned.It was noted the trocar was returned for evaluation.The infusion cannula tip was measured by inserting the 25 gauge (ga) into the go-no-go gauge and confirmed the cannula tip to be 25ga.The infusion cannula tip was then inserted into a 25ga trocar and could fully engage together with no anomalies observed.It was confirmed 25ga trocars and 25ga infusion cannula was built into this finished goods lot.A review of the lot history indicates this issue to be an isolated event for this finished goods lot.The root cause of the customer's complaint could not be established as the returned met specifications.After investigation of this complaint, it has been determined that this sample met specifications; therefore, no corrective action is required at this time.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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