Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.The investigation is inconclusive for the alleged thrombus issue as no objective evidence has been provided to confirm any alleged deficiency with the filter.A definitive root cause for the alleged thrombus issue 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: this supplemental mdr is being submitted to report that mfr rpt# 2020394-2022-00324 was a duplicate record and was opened in error.The event details are being captured under complaint file # (b)(4) and was reported to the fda under mfr rpt# 2020394-2016-00229.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 : device not returned.
|