H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one powerport implantable port attached to a groshong catheter in two segments were returned for evaluation.Functional, gross visual, tactile, and microscopic visual evaluations were performed.The investigation is confirmed for the reported fracture and material separation issues and identified wear and deformation issues, as a partial circumferential break was noted approximately 3.4cm from the distal end of the cath-lock.Complete circumferential breaks were noted on the distal end of the attached catheter and on the proximal end of the distal catheter segment.The surface of the partial circumferential break on the attached catheter was noted to be round and granular.The surfaces of the complete circumferential break on the distal end of the attached catheter and proximal end of the distal catheter segment were noted to be granular and glossy.However, the investigation is inconclusive for the reported migration issue, as the exact circumstances at the time of the reported event cannot be verified, and the reported event could not be reproduced in the lab.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: 03/2020).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 approximately six years and six months post port placement, the catheter was allegedly broken.It was further reported that distal catheter segment migrated into the heart.Reportedly, the distal catheter segment was removed.The current status of the patient is unknown.
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