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 low profile port attached to a groshong catheter was returned for evaluation.One electronic photo was also provided for review.Gross visual, microscopic and functional testing were performed.Based on the sample evaluation, the investigation is confirmed for unable to aspirate, cath-lock damage and fracture as tool damage and scoring were identified on the cath-lock.A circumferential split was noted from the distal end of the cath-lock.The port body and attached catheter were patent to infusion and aspiration with a leak noted at the circumferential split.Also, aspiration of water into the syringe was attempted but was unsuccessful, air was aspirated into the syringe.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.(expiry date: 05/2022).
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