Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport mri isp implantable port attached to a groshong catheter was returned for evaluation.Gross, microscopic visual, tactile evaluation and functional testing were performed.The investigation is unconfirmed for the reported material separation issue as the catheter was found intact and no segments of catheter was returned for evaluation.However, the investigation is confirmed for the reported catheter fracture and fluid leak and identified deformation and wear issues as a split was noted on the attached catheter approximately 0.1cm from the distal end of the cath-lock.Further, a partial circumferential break and partial compound break were noted on the attached catheter approximately 1.4cm and 2.0cm from the distal end of the cath-lock respectively.Under microscopic observation, the edges of the partial circumferential break on the attached catheter was noted to be uneven.Also, the edges of the partial compound break on the attached catheter was noted to be jagged and the surface was noted to be round in one region and granular in the one region.Upon infusion, a leak from both partial breaks on the attached catheter were noted.The identified break is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of 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: 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.
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