Model Number 384232 |
Device Problem
Fracture (1260)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 03/06/2023 |
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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During placement of a picc line, when attempting to redirect the catheter, the catheter fractured, leaving approximately 9cm piece of picc line retained in the patient.Appropriate action was taken immediately to prevent migration and removed the fractured piece of line.¿ *per the mdr/medwatch, the product is available for return.Initial reporter asked to remain confidential.
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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.According to the customer, there was no sample available for review.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.However, due to the number of complaints against this lot for breakage/leakage this complaint will be confirmed.Since a sample was not returned for review, an evaluation could not be conducted to establish a possible root cause and corrective action.Argon will continue to monitor for recurrence.
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Event Description
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During placement of a picc line, when attempting to redirect the catheter, the catheter fractured, leaving approximately 9cm piece of picc line retained in the patient.Appropriate action was taken immediately to prevent migration and removed the fractured piece of line.¿ per the mdr/medwatch, the product is available for return.Initial reporter asked to remain confidential.
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Search Alerts/Recalls
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