It was reported that two years and eleven months post port placement procedure, the port was allegedly had a leak.It was further reported that catheter had two holes in the subcutaneous part.Reportedly, patient experienced burning sensation and inflammation which required treatment with antibiotics.The port system was removed.The current status of the patient is unknown.
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H10: 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 powerport mri isp implantable port attached to a groshong catheter was returned for evaluation.Gross visual, microscopic visual, tactile evaluation and functional testing were performed.The investigation is unconfirmed for the reported catheter hole issue as fracture was identified during return sample evaluation.However, the investigation is confirmed for the reported fluid leak and identified fracture, wear and deformation issues as a two partial circumferential breaks were noted approximately 7.8cm and 8.4cm from the distal end of the cath-lock.Under microscopic observation, the surface of both the partial circumferential breaks were noted to be round and glossy in both region.Further, a split was noted on the catheter approximately 7.2 cm, proximal to the partial circumferential breaks.Upon infusion, leaks were observed from the partial circumferential breaks on the catheter.Furthermore, clinical conditions alleged in the complaint such as burning sensation and inflammation cannot be confirmed.The identified break is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.The definitive root cause could not be determined based upon 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: 02/2021), g3, h6 (device).H11: g1, h6(method, result, 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.H3 other text : see h10.
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It was reported that two years and eleven months post port placement procedure, the port was allegedly had a leak.It was further reported that catheter had two holes in the subcutaneous part.Reportedly, patient experienced burning sensation and inflammation which required treatment with antibiotics.The port system was removed.The current status of the patient is unknown.
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