Catalog Number H96560M7801261 |
Device Problems
Obstruction of Flow (2423); Malposition of Device (2616)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/12/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Although no sample is being returned for evaluation, the investigation into this event is on-going.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
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Event Description
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As reported by hospital in (b)(6): picc placed (b)(6) - hd etoposide give (b)(6).Xray ordered by physician for improperly functioning picc (b)(6) - seen coiled in svc - could not be flushed.Was removed and replaced (b)(6) - line noted to be discolored.Hospital has stated that the dfu for etoposide lists polyurethane as contraindicated.
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Manufacturer Narrative
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A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The recent angiodynamics complaint report was reviewed for the complaints reported for the bioflo picc product family and the failure mode "aspiration difficulty - removed." no adverse trend was identified.We reviewed our chemical testing associated with the bioflo picc catheter tubing and confirmed that etoposide is not a new drug and it was included in our chemical compatibility evaluation.A drug representing this class of chemotherapy agents was tested.Etoposide is generic drug name but review of one manufacturer's directions for use of their drug cautioned against using the drug undiluted.The undiluted use of the etoposide drug is a potential root cause for the issues experienced with the bioflo picc device.The end user hospital has stated that they are now diluting this drug for treatment.((b)(4)).
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Search Alerts/Recalls
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