Model Number 384539 |
Device Problem
Crack (1135)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/11/2023 |
Event Type
malfunction
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Event Description
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I have another cracked picc in my office here for evaluation.This one was discovered (b)(6) 2023 in situ in a patient less than 12 hours after insertion.Patient had a picc inserted that had to be removed after a short duration because of a crack in the hub.They were then left without central access and had subsequent attempts for access.
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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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I have another cracked picc in my office here for evaluation.This one was discovered (b)(6)2023 in situ in a patient less than 12 hours after insertion.Patient had a picc inserted that had to be removed after a short duration because of a crack in the hub.They were then left without central access and had subsequent attempts for access.
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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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Search Alerts/Recalls
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