Correction - initial medwatch, lot # should be unknown, expiration date should be unknown, device manufacture date should be unknown.In lieu of a reported lot number, a ship history report (shr) was generated for item number h96560m7801261 in order to determine the last three lots shipped to the reporting hospital in the six months prior to the procedure date.The three lots obtained through the shr were: (5289472, 5285643 and 5277220).The device history records for the lots obtained through the ship history report (packaging lots) were reviewed 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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