H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one broviac s/l catheter was returned for evaluation.Gross, microscopic visual, functional testing and tactile evaluation were performed.During visual evaluation, the tissue cuff was intact and had residue.Suture wire was noted tied to the catheter distal to the tissue cuff.Under microscopic observation, the tissue cuff was noted to be glossy and matted with residue throughout.However, the investigation is inconclusive for the reported loosening of implant issue as the exact circumstances at the time of reported event cannot be verified.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.H10: g3, h6 (method) h11: g1, h6 (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.
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