Catalog Number PR-35052-HPHNM |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2022 |
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 during ct abdomen with contrast, the picc lumen was accessed appropriately (pink lumen aspirating and flushing prior to connection of contrast), however when radiographer attempted to start contrast injection at 2.5ml/sec, injector indicating high pressure.Scan stopped and picc inspected.Pt stated he heard a noise from his picc and then felt moisture on his pillow.On inspection of the picc, a split was noted on the white catheter below the level of the hub.The picc was secured and the picc was removed on the ward.No patient harm reported.The patient's condition is reported as fine.
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Event Description
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It was reported during ct abdomen with contrast, the picc lumen was accessed appropriately (pink lumen aspirating and flushing prior to connection of contrast), however when radiographer attempted to start contrast injection at 2.5ml/sec, injector indicating high pressure.Scan stopped and picc inspected.Pt stated he heard a noise from his picc and then felt moisture on his pillow.On inspection of the picc, a split was noted on the white catheter below the level of the hub.The picc was secured and the picc was removed on the ward.No patient harm reported.The patient's condition is reported as fine.
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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 one relevant finding was identified.A non-conformance was initiated for lot 13p21f0249 in regard to resin not according to specification.Without the sample returned, it cannot be determined if the failure mode of this complaint is the same as the non-conformance 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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Search Alerts/Recalls
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