H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: one hemosplit long-term dialysis catheter was returned for evaluation.Visual, microscopic and functional testing were performed.Stretching to the red luer extension leg was noted distal to the distal end of the luer.The sample was returned with both clamps disengaged.The tissue cuff was intact and had residue.Both lumens were patent to infusion and aspiration with no issue.The investigation is confirmed for the bulged catheter, as a bulge on the red luer extension leg was clearly noted.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 (05/2021), g4.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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