Manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: one mri hard base port attached to a groshong catheter was returned for evaluation and one electronic photo was provided for review.Visual, microscopic visual and functional evaluation were performed.The investigation is confirmed for the reported aspiration issue and catheter fracture and scratched material as the port body and attached catheter were patent to infusion and aspiration with a leak noted at the splits and air was aspirated into the syringe upon aspirating the water, multiple splits were noted approximately 2mm from the distal end of the cath-lock and scoring was noted on the cath-lock.Based upon the available information a definitive root cause could not be determined.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.The catalog number identified has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products are identified in procode and pma/510k.(expiry date: 11/2022).
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