Model Number 384539 |
Device Problem
Crack (1135)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Type
malfunction
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Manufacturer Narrative
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The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
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Event Description
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¿reported issue: bedside nurse that patient was bleeding copiously from picc in rue.Writer assessed site and noted that bleeding did not appear to come from the insertion site.On further inspection picc hub noted to be cracked at the plastic hub that connects to luer lock adapter this necessitated an immediate new picc placement.¿.
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Manufacturer Narrative
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A review of the dhr and inspection records was conducted, and no similar concerns were found.One opened catheter was returned for review.Visual inspection confirmed a crack in the luer that would result in leakage.Several complaints for this part number have previously been received regarding a cracked hub resulting in leakage, and capa 2021-039 was initiated to address this issue.The capa is currently in the implementation phase and will evaluate the corrective action implementation for effectiveness to prevent a recurrence of this issue.
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Event Description
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¿reported issue: bedside nurse that patient was bleeding copiously from picc in rue.Writer assessed site and noted that bleeding did not appear to come from the insertion site.On further inspection picc hub noted to be cracked at the plastic hub that connects to luer lock adapter this necessitated an immediate new picc placement.¿.
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Search Alerts/Recalls
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