Model Number 1003330 |
Device Problems
Leak/Splash (1354); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2022 |
Event Type
malfunction
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Event Description
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It was reported that during preparation of 2 copilots the valves were reported to have leaks in the proximal hub.The leaks were noted during injection of the contrast.There was no patient involvement and no clinically significant delay reported in the procedure.No additional information was provided.
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Manufacturer Narrative
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The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The other copilot device referenced is filed under a separate medwatch report number.
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Event Description
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Subsequent to the initial medwatch report, it was reported that there was only one copilot that was used in the procedure.This device was reported in error.No second device used.No event to be reported.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A similar incident query was not performed as there was no reported device issues for the complaint.Not applicable as this complaint was wrongly reported by the hospital as there was only one device that presented an issue (reference: cn-128075).There is no indication of a product quality issue with respect to manufacture, design or labeling.B5: description of event d9, h3: there was only one device used in the procedure.This device was not used in the procedure.Reported in error.No device to be returned for evaluation.H6: medical device problem code 1354 - removed.
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Search Alerts/Recalls
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