H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary:one powerport with a groshong catheter in two segments was returned for evaluation.Visual, microscopic visual and functional evaluations were performed.The investigation is confirmed for catheter fracture, deformation, catheter tip migration and wear issue as two circumferential kinks were noted approximately 8.3cm and 9.0cm from the distal end of the cath-lock, a complete circumferential break was noted approximately 10.7cm from the distal end of the cath-lock and a circumferential kink was noted approximately 1.9cm from the proximal end of the distal segment.Additionally, the edges of the circumferential split were jagged and both edges of the circumferential break were jagged with a both a smooth rounded and granular surface.A 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: g4.H6(device: 2988).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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