As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2024).
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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: the device was not returned for evaluation, one electronic photo was provided for review.The photo shows on navarre opti drain drainage catheter inserted with a trocar stylet.The trocar stylet looks extended beyond the tip of the drainage catheter than usual length.However it is unknown whether the cannula was used to insert the trocar stylet to the catheter as mentioned in the instruction for use.Therefore the investigation is inconclusive for the reported defective component issue as the provided photo is not sufficient to confirm the reported issue and the physical device was not returned for evaluation.The 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.Instruction for use states: 4.Prepare the drainage catheter for insertion by advancing the cannula into the drainage catheter, ensuring that rubber seal is not over the indent.Lock the cannula hub into position.5.Use diagnostic imaging to direct the catheter into fluid collection site.(use the seldinger or trocar technique.) 6.Remove the cannula and guidewire or the trocar stylet.7.Lock the catheter loop.D4 (expiry date: 02/2024).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.
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