H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one 12f navarre drainage catheter was returned for evaluation.Gross visual and microscopic visual evaluation were performed.The investigation is confirmed for the reported hub fracture and identified material separation issues as a complete fracture was noted on the proximal end of the catheter hub.Under microscopic observation, the fractured surface on the hub was noted to be jagged and uneven.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.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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