Model Number 384516 |
Device Problem
Coagulation in Device or Device Ingredient (1096)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device is indicated as available for return, at the time of this report, the device has not been returned.A follow-up report will be submitted once the device has been returned and evaluated.
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Event Description
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Clotted picc.Poss cracked hub¿.
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Manufacturer Narrative
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A review of the dhr and inspection records was not conducted since a lot number was not provided.One catheter was returned for review.Visual inspection of the sample confirmed a crack in the female luer which would result in leakage.The hub was covered in a sticky residue.Several complaints have previously been received regarding a cracked hub resulting in leakage, and capa 2021-039 has been initiated to address this issue and is currently under investigation.The capa will identify the specific causes and corrective actions to be taken.
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Event Description
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Clotted picc.Poss cracked hub¿.
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Search Alerts/Recalls
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