As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
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H10: manufacturer review: a lot history record could not be completed as the lot number was not provided.Investigation summary: the device has not been returned for evaluation, therefore, the investigation is inconclusive for failure to catheter occlusion as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.H10: journal article citation: kopec, g., waligóra, m., stepniewski, j., & podolec, p.(2018).Indwelling central venous catheter occlusion during chronic epoprostenol infusion.The journal of heart and lung transplantation, 37(7), 938¿940.Doi: 10.1016/j.Healun.2018.03.018 h10: g4, journal article citation, and article attachment.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.- attachment: [2018 - kopec, g.Pdf].
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