H10: manufacturing review: a lot history review, a dhr review, and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one broviac repair catheter was returned for evaluation.Visual and functional evaluation were performed on the returned device.The investigation is confirmed for catheter break as a longitudinal split was observed on the distal end of the catheter.Both inner and outer catheter lumen had a circumferential break.Further the investigation is confirmed for suction issue since an unsuccessful attempt was made aspirating the catheter.A definitive root cause could not be determined based upon the 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.H11: d1, d4, h6 (patient, device, method, result and 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.
|