It was reported that post port device implant, the patient allegedly experienced numbness and pain.It was further reported that the device was explanted and replaced.However, the injury was suspected to be because of the device leak, which should have been caused due to device fracture.The current status of the patient is unknown.
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It was reported through the litigation process that post port device implant, the patient allegedly experienced numbness and pain.It was further reported that the device was explanted and replaced.However, the injury was suspected to be because of the device leak, which should have been caused due to device fracture.The current status of the patient is unknown.
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H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.Therefore, a device history record review is not required.Investigation summary: the sample was not returned for evaluation, a medical record review was performed.The investigation is confirmed for the reported port flipped issue.According to the medical record, approximately one year and ten months post filter deployment, contrast evaluation of a subcutaneous chest infusion port revealed that a left-sided chest infusion port with the catheter tip at the confluence of the innominate veins and abutted the right lateral wall of the most proximal superior vena cava.Malpositioned and malfunctioned left chest subcutaneous infusion port noted.Two days later, the patient scheduled for removal and replacement of port device.After the administration of local anesthesia, an incision was made in the left upper chest adjacent to the port reservoir.Using blunt dissection the reservoir was freed, and the port and catheter were removed.They were inspected and confirmed to be removed in their entirety.Successful placement of the right internal jugular vein subcutaneous chest infusion port and removal of the left chest subcutaneous infusion port was achieved.However, the reported clinical conditions alleged in the complaint could not be confirmed from the medical record review.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.H10: d4 (expiry date: 03/2021), g3, h6 (method).H11: b5, g2, h6 (device, result, conclusion).H11: section a through f ¿ the information provide by bd represents all 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.H3 other text : device not returned.
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