H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one bardport implantable port attached to a catheter was returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.The investigation is confirmed for the reported catheter fracture, and the identified material separation, wear and deformation issues, as a complete circumferential break was noted on the distal end of the catheter and the surface was noted to be granular in one region and round in the other region and kinks were noted throughout the catheter.Furthermore, a longitudinal split was noted at the border of both regions.The identified break is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.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: g3, h6 (device).H11: h6 (method, 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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