H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one titanium implantable port attached to a groshong catheter was returned for evaluation.Gross visual, microscopic visual, tactile and functional evaluation were performed on the returned device.The investigation is confirmed for the identified peeled and degraded issues as the catheter was noted to be degraded from the 15.0cm depth mark to the 16.0cm depth mark and the catheter material appeared to be peeled off in the same region.Further, the investigation is also confirmed for the reported fluid leak and identified fracture issue as a partial c-shaped break was noted to be jagged.During functional evaluation, a leak was noted from the longitudinal split upon infusion.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: d4 (expiration date: 12/2011).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.
|