H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one introducer needle was returned for evaluation.Gross, microscopic visual and functional testing were performed.The investigation is confirmed for the identified needle fracture issue as multiple cracks were observed on the proximal needle hub.Upon infusion, a leak was observed from the needle hub.However, the investigation is unconfirmed for the reported limited information issue as fracture was identified on the returned physical sample.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 (expiration date: 11/2022).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.
|