Catalog Number CS-22142-CF |
Device Problem
Partial Blockage (1065)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).
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Event Description
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It was reported that the doctor notices that the catheter was folded at the level "15" after insertion in the patient.Clinical consequences: issue with the "way-back" with one of the line of the catheter.Necessary to switch lines in the beginning of the dialysis.The blood flow was half what it should have been.So , the dialysis was less effective.
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Manufacturer Narrative
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(b)(4).The customer returned only the lidstock for evaluation.The actual complaint sample was not returned for investigation; therefore, visual inspection could not be performed as no sample was returned for analysis.Complaint verification testing could not be performed as no device sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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It was reported that the doctor notices that the catheter was folded at the level "15" after insertion in the patient.Clinical consequences: issue with the "way-back" with one of the line of the catheter.Necessary to switch lines in the beginning of the dialysis.The blood flow was half what it should have been.So , the dialysis was less effective.
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Search Alerts/Recalls
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