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.The device has not been returned to the manufacturer for evaluation.H3 other text : device not received.
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It was reported that the patient required a midline iv to be placed by a qualified interventional radiology registered nurse, which reported to have been inserted with no issues.The patient¿s condition decompensated, and she required an intensive care consult with additional oxygen need and vasopressors.A ct (computerized tomography) of the chest/abdomen/pelvis without contrast was ordered.In the reading, there was noted to be a new \linear metallic density within the right and left pulmonary arteries, favored to represent a foreign body such as a catheter or guidewire fragment¿.A ct performed 3 days prior to the midline insertion did not show the foreign body.Additional information received 03/01/2024: it was reported the foreign material was never removed prior to expiration.We cannot confirm it had an effect on the outcome, only that it was identified on imaging.
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