Catalog Number CDC-45552-VPS2 |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
Brain Injury (2219)
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Event Date 04/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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The customer reported after placing the line successfully with a bbe, the patient was transported to another location (maine medical center), and found the picc was 4cm deeper than what was reported at placement with the device.The catheter was pulled back and confirmed under fluoroscopy.
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Event Description
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The customer reported after placing the line successfully with a bbe, the patient was transported to another location (maine medical center), and found the picc was 4cm deeper than what was reported at placement with the device.The catheter was pulled back and confirmed under fluoroscopy.
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Manufacturer Narrative
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Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Vps r and d reviewed the case data provided by the customer.The stylets used during the procedures were not returned for evaluation.Each of the procedure datasets were reviewed looking for indications of abnormal system behavior that may have attributed to the deep catheter placement, but during the review of the procedures there were no indications of any abnormal system behavior.Vps r and d concluded with the information available to investigate the deep catheter placements, it was not possible to determine an abnormal system behavior that would have led to the catheters being placed too deep.A device history record review was performed and did not reveal any manufacturing related issues.A probable cause of this issue could not be determined based on the information provided and without a sample.No further action will be taken.Teleflex will continue to monitor and trend for reports of this nature.
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Search Alerts/Recalls
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