ARROW INTERNATIONAL INC. ARROW CANNON II PLUS REPLACEMENT HUB SET; KIT, REPAIR, CATHETER, HEMODI
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Catalog Number CAR-02400 |
Device Problem
Crack (1135)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/12/2017 |
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 reports that a patient had a pemcath inserted 2 months ago, and a week ago presented with a cracked hub on one of the lumen, they changed the hub and inserted car02400, she has now returned with the hub leaking (documented in mdr# 1036844-2017-00456).
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The lot number was not provided by the customer; therefore, a device history record review was performed based on the sales history of the customer.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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The customer reports that a patient had a pemcath inserted 2 months ago, and a week ago presented with a cracked hub on one of the lumen, they changed the hub and inserted car02400, she has now returned with the hub leaking (documented in mdr# 1036844-2017-00456).
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Search Alerts/Recalls
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