The catalog number identified in section has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products are identified in common device name and pma/510k.Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one bardport mri l/p implantable port, one cath-lock loaded to a catheter, two introducer needles, one right-angle non-coring needle, one cath-lock, one syringe, one 7.0fr peel-apart sheath and vessel dilator, and one tunneler were returned for evaluation.Functional, gross visual, and microscopic visual evaluations were performed.In addition to the returned physical sample, three electronic photos were provided for review.Therefore the investigation is inconclusive for the reported material integrity issue as the exact circumstances at the time of the reported event was unknown.However the investigation is confirmed for the identified deformation issue as the distal tip of the vessel dilator was noted to be deformed.A definitive root cause could not be determined based upon the 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.(expiry date: 06/2024).
|