No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one d/l hemostar catheter was returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is confirmed for extension leg separation from bifurcation, as the blue hub extension leg was separated from the bifurcation and break surfaces were observed on the distal end of the extension end and the proximal end of the bifurcation on the main catheter.The break surfaces appeared smooth and had striations mostly aligned towards the center of the lumen.Some damage was observed near the inner edge on the extension leg break surface.The definitive root cause could not be determined based upon available information.It is unknown if procedural issues contributed to the reported event.Excessive and/or repeated stresses and/or torques may have contributed to the reported extension leg separation from the bifurcation.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: d4 (expiration date: 07/2019), d10, g4, h6 (device codes).H11: h3, h6 (method, results, conclusions).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.
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