The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "incorrect set- up / incorrect tooling / incorrect parameters / not enough material".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following:
"sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single use only.Do not re-sterilize.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use.Proper techniques for urinary catheter insertion
perform hand hygiene immediately before and after insertion
insert urinary catheters using aseptic technique and sterile equipment
use the smallest foley catheter possible, consistent with good drainage
document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in the patient record
* generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.However, drainage is sometimes accomplished by
suprapubic or other placement of the catheter, such as nephrostomy tract.¿ to assist in healing of open sacral or perineal wounds
¿ patient requires prolonged immobilization
¿ to improve comfort for end of life care
¿ patient has acute urinary retention or bladder outlet obstruction
¿ need for accurate urine output measurements
¿ use for selected surgical procedures
secure the foley catheter.Use the statlock® foley stabilization device if provided maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions maintain unobstructed urine flow and keep the catheter and collection tube free from kinking
keep the collection bag below the level of the bladder or hips at all times empty the collection bag regularly using a separate, clean collection container for
each patient."
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 : the device was not returned.
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