H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport isp mri implantable port attached to a groshong catheter was returned for evaluation.Gross visual, microscopic visual and functional evaluations were performed on the returned device.During functional evaluation, the catheter was unable to be infused as leak was noted through the partial circumferential break upon infusion.However, the investigation is inconclusive for the reported infusion issue as the exact circumstances at the time of the reported event are unknown and the reported infusion problem occurred almost five months ago as to when the catheter fracture was reported, so the identified catheter fracture not considered as the cause of the reported infusion problem.The definitive root cause could not be determined based upon available information.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: g3.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.
|