The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.
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The reported event was confirmed.The samples in the photo were in used condition.The visual evaluation noted that the devices were blunt.It could not be determined which of the devices were associated with which lot using the photos.It could not be confirmed which sample was from which lot once the packages had been opened and the devices were mixed as they were in the photo.The photo included 8 devices and it could be seen that the tapered feature was not present.It was determined that the tapered end of the product did not meet specifications.The tip of the device could not be evaluated to determine if the device could be passed through a french size 13 as required.However, it was observed from the photo that the devices pictured did have blunt tips that did not appear tapered.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "bard® heyman¿ followers are intended to be used with bardex® councill catheters and bard® heyman¿ filiform catheters.All individual devices are disposable and sold sterile.The filiform catheter comes packaged with a disposable stylet to use for insertion.Insert the bard® heyman¿ filiform catheter with stylet in place.The filiform catheter may be placed by inserting through a cystoscope under direct vision.Direct view catheter placement will decrease the number of difficult and possible false passages.There is a 3 centimeter orientation marking on the filiform catheter at 30 centimeters from the distal end to assist with placing the filiform catheter in the bladder.Placement of the filiform catheter in the bladder can be determined by removing the stylet and observing urine or aspirating urine with a syringe.If added confirmation is necessary, a radio graph can be taken after injecting radiopaque dye into the filiform catheter.When the filiform catheter has been properly placed, the stylet should be discarded.Starting with the smaller sizes, slip the bard® heyman¿ followers (straight or coude) over the filiform catheter.Increase the follower size until the desired dilation is accomplished.Slip a bardex® councill catheter over the filiform catheter and when it is in place, inflate balloon.Remove the filiform catheter.If, at a later time, the councill catheter is to be replaced, insert a new filiform catheter prior to removing the councill catheter.The filiform catheter will then guide the new councill catheter into place.After use, this product may be potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Warning: because the filiform catheter may advance with the passage of the followers, a length of the filiform catheter should always appear beyond the proximal end of the follower, otherwise the filiform catheter may be left in the urethra when the follower is withdrawn.".
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