It was reported that approximately one year post port device implant via right internal jugular vein, the healthcare provider was allegedly unable to aspirate through the port device.It was further reported that the patient allegedly experienced chest distress and palpitation.Therefore, an x-ray imaging was performed which allegedly identified that the catheter fractured and migrated to the heart.Reportedly, the catheter and the port body were removed under digital subtraction angiography (dsa) and upon removal an alleged catheter fracture was identified at the cathlock.The patient status is unknown.
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H10: manufacturing review: manufacturing records were reviewed (dhr, mrr¿s, scrap and mfg.Process changes) and there were not found evidence that the failure mode reported in this complaint is caused by the mfg.Process.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.Ifu reviewed: baw0735041, rev.0 investigation summary: although the sample was not returned for evaluation, two electronic photo samples were provided for review.The investigation is confirmed for a catheter break at the cathlock, as the photos appear to show the catheter break at the cathlock and the catheter that embolized to the heart.Although a definitive root cause could not be determined, flex fatigue, kinking, and excessive tensile forces could have potentially caused or contributed to the reported event.H10: d4 (expiration date: 09/2020), g4 h11: a3, h6 (method, results, conclusion) 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.
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It was reported that approximately one year post port device implant via right internal jugular vein, the healthcare provider was allegedly unable to aspirate through the port device.It was further reported that the patient allegedly experienced chest distress and palpitation.Therefore, an x-ray imaging was performed which allegedly identified that the catheter fractured and migrated to the heart.Reportedly, the catheter and the port body were removed under digital subtraction angiography (dsa) and upon removal an alleged catheter fracture was identified at the cathlock.The patient status is unknown.
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