H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex that are cleared in the us.The pro code and 510 k number for the rotarex are identified in d2 and g4.H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical sample was returned for evaluation.A catheter was physically investigated.The catheter was blocked due to a high amount of blood and coagulation material in the catheter.After flushing functionality could be reestablished and normal aspiration level reached.No malfunction was detected.Regarding the user report it is assumed there was a temporary occlusion of the catheter during the intervention.The instructions for use describes the procedure for flushing a clogged catheter to reestablish functionality.This case is a usage error, since the flushing of the catheter was failed during the treatment.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy h10: d4 (expiration date: 05/2024), g3, h6 (device).H11: h6 (method, result, conclusion).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.H3 other text : see h10.
|