As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us, but is similar to the x-port isp implantable port, groshong single-lumen, 8f products that are cleared in the us.The pro code and 510 k number for the x-port isp implantable port, groshong single-lumen, 8f products are identified.
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H10: manufacturing review: a lot history review, a device history record review, and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one groshong catheter segment was returned for evaluation.Visual, microscopic and functional evaluation were performed.The investigation is confirmed for the reported catheter fracture as a circumferential break was noted to the proximal end of the catheter segment.However, the investigation is inconclusive for the reported catheter migration as the reported event cannot be replicated in the laboratory.A 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: the catalog number identified in section d4 has not been cleared in the us, but is similar to the x-port isp implantable port, groshong single-lumen, 8f products that are cleared in the us.The pro code and 510 k number for the x-port isp implantable port, groshong single-lumen, 8f products are identified in d2 and g5.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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