H10: manufactuing review: a manufacturing review could not be completed as a lot number was not provided.Investigation summary: one ti low-profile port with groshong catheter in two segments and cath-lock was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.The investigation is confirmed for a complete catheter break due to flexural fatigue, as two catheter segments were returned with the sample.The catheter cross-section break surface at the proximal end of the distal catheter segment had a rough and granular region with sharp edges and a smooth region with rounded edges.The catheter cross-section break surface at the distal end of the proximal catheter segment also had a region with a smooth surface and round edges.Both cross-section profiles appeared to have a flattened elliptical shape.There appeared to be catheter buckling near the distal end of the proximal catheter segment.The port body and catheter segments were separately patent to infusion and aspiration with no leaks noted.The findings from the investigation are consistent with a full catheter break due to flexural fatigue.Placement, usage, physiological, material and/or mechanical factors may contribute to cyclic kinking in the catheter which may gradually form a crack/break in the catheter.Labeling review:the cause of the event in question is unknown, and so the applicability of any particular portion of the ifu or other labeling is unknown.However, a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the ifu instructs on catheter and port insertion and placement, and therefore the product labeling will be considered adequate.H10: g4; h6: device code (2889 deformation due to compressive stress, 1562 material separation, 2923 dislodged or dislocated) h11: h3, h6 (device code, results, 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.
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