As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2022).
|
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: manufacturing review: a complaint history review was performed.This is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: the sample was not returned for evaluation.Two electronic photos were provided for review.Therefore, the investigation is confirmed for the reported detachment of device issue as suture plug was seen detached from the port.A definitive root cause 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: 01/2022), g3, h6(method).H11: h6(device, result, conclusion).H11: section a through f: the information provide by bd represents all 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.
|