As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for evaluation; however, photos have been provided.The investigation of the reported event is currently underway.Expiry date: 01/2021.
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H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the sample was not returned for evaluation, however, seven electronic photos were provided for review.The investigation is confirmed for particulate within the catheter, as the photo review showed whitish clumped particulate within the extension legs, particularly the venous lumen.A 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 : 01/2021), 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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