Catalog Number SAC-01218-PBX |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 09/09/2021 |
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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It was reported that: "there was a untimely bleeding at the puncture point during the insertion of the catheter." the user reports the puncture needle makes a hole larger than the diameter of the catheter, resulting in heavy bleeding.No patient harm or consequence reported.A hemostatic compression bandage was applied.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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: "there was a untimely bleeding at the puncture point during the insertion of the catheter." the user reports the puncture needle makes a hole larger than the diameter of the catheter, resulting in heavy bleeding.No patient harm or consequence reported.A hemostatic compression bandage was applied.
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Search Alerts/Recalls
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