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 23cm hemosplit d/l catheter was returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.In addition to the returned physical sample, one electronic photo was provided for review.The red luer extension leg was noted to be bubbled, proximal to the catheter hub.The photo review also confirms the same.Therefore the investigation is confirmed for the reported material protrusion and stretched issue.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: 07/2023).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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