As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.However, video was provided for review.The investigation of the reported event is currently underway.(expiry date: 10/2021).Device pending return.
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H10: manufacturing review: a complaint history review was performed.This is the second complaint reported for this product/lot number combination.The device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary: one flushing connector was returned for evaluation.Gross visual, functional and microscopic evaluations were performed.Although sample was returned for evaluation, one video was provided for review.The investigation is confirmed for the reported unable to flush and obstruction of flow issue, as the flushing connector could not be flushed nor aspirated.Destructive testing was performed on the device by breaking the metal from the hub.An unknown white, plastic-like material obstructing the flow path of the flushing connector was identified.The occlusion material was determined to be excess material from the hub itself and prevented a proper flushing of the device.This condition was caused during the over-molding process.Therefore, the cause of this condition is manufacturing related.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.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.H3 other text : see h10.
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