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 dualok localization wire was returned for evaluation.On visual evaluation, the device appeared clean and the device was received without the female luer lock hub and cannula.On further evaluation, it was noted that the one dual locking element was noted to be broken from the localization wire.Therefore, the investigation for the reported break is confirmed as the breakage to the one dual locking was noted during the evaluation.A definitive root cause for the alleged break could not be determined based upon the provided 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: 03/2024), g3, h6 (method) h11: h6 (result, conclusion) 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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