H10: 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.Functional, gross visual, tactile and microscopic visual evaluations were performed.The investigation is confirmed for the identified fracture and the identified wear and deformation issues, as a partial circumferential break was noted approximately 8.4cm from the distal end of the cath-lock.A partial compound break was noted approximately 9.2cm from the distal end of the cath-lock.The surface of the partial circumferential break on the attached catheter were noted to be granular and glossy in both regions.The surface of the partial compound break on the attached catheter were noted to be granular and glossy in both regions.However, the investigation is inconclusive for the reported pain issue, as the exact circumstances at the time of the reported event cannot be verified.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.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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