Model Number 384539 |
Device Problems
Crack (1135); Leak/Splash (1354)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/25/2022 |
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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¿l-cath picc s/l 26 gauge inserted into patient; after insertion noted that it was leaking.Once removed, identified a crack that was the root cause.¿.
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Manufacturer Narrative
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The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
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Event Description
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¿l-cath picc s/l 26 gauge inserted into patient; after insertion noted that it was leaking.Once removed, identified a crack that was the root cause.¿.
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Event Description
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¿l-cath picc s/l 26 gauge inserted into patient; after insertion noted that it was leaking.Once removed, identified a crack that was the root cause.¿.
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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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