Catalog Number 1008193-30 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The other two 5 x 30 mm rx viatrac plus devices referenced are filed under separate medwatch report numbers.
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Event Description
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It was reported that the part number on the international label ((b)(6)) on the boxes of three 5 x 30 mm rx viatrac plus peripheral dilatation catheters did not match the part number on the english label.The label discrepancy was noted at the distribution center.The dilation catheters were not used.There was no patient involvement.No additional information was provided.
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Event Description
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Clarification: the label discrepancy was noted at the distributor in (b)(6).
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Manufacturer Narrative
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(b)(4).The device was returned for analysis and the labeling discrepancy was confirmed.The investigation determined the labeling issue appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
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Search Alerts/Recalls
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