It was reported that the customer started using the old bard kits due to surestep production issues.It was stated that (b)(6) campus started using them about 5 weeks ago and clear lake campus started using them approximately 2 weeks ago.The customer noticed a great increase in catheter associated urinary tract infection in (b)(6) campus and they were beginning to do the same at (b)(6) campus.Also stated that when they started rounding with staff, they reported that these catheters leaked, and they were having to replace them more than usual.It was stated that during bundle rounds the previous day, one patient was leaking and that day they suspected two catheters were leaking due to discoloration of the statlock.The customer questioned whether we have specific instructions for these catheters that could prevent this.It was unknown what medical intervention was provided for urinary tract infection.
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It was reported that the customer started using the old bard kits due to surestep production issues.It was stated that (b)(6) started using them about 5 weeks ago and (b)(6) started using them approximately 2 weeks ago.The customer noticed a great increase in catheter associated urinary tract infection in (b)(6) and they were beginning to do the same at (b)(6).Also stated that when they started rounding with staff, they reported that these catheters leaked, and they were having to replace them more than usual.It was stated that during bundle rounds the previous day, one patient was leaking and that day they suspected two catheters were leaking due to discoloration of the statlock.The customer questioned whether we have specific instructions for these catheters that could prevent this.It was unknown what medical intervention was provided for urinary tract infection.
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The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to "materials of construction are not biocompatible".The device was not returned for evaluation.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: "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 patient record.Proper techniques for urinary catheter maintenance: 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 (e.G., prior to transport) using a separate, clean collection container for each patient.Routine hygiene (e.G., cleansing of the meatal surface during daily bathing or showering) is appropriate.Leave foley catheter in place only as long as needed.Directions for use: 1.Wash hands and don clean gloves.3.Use the provided packet of wipes to cleanse patient¿s periurethral area.2.Explain procedure to patient and open peri-care kit.4.Remove gloves and perform hand hygiene with provided alcohol hand sanitizer gel.5.Using proper aseptic technique open csr wrap.6.Do sterile gloves.7.Place underpad beneath patient, plastic/ ¿shiny¿ side down.Note: use caution to maintain aseptic technique.8.Position fenestrated drape on patient.9.Saturate 3 foam swab sticks in povidone iodine.10.Attach the water filled syringe to the inflation port.Note: it is not necessary to pre-test the foley catheter balloon.11.Remove foley catheter from wrap and lubricate catheter.12.Prepare patient with 3 foam swab sticks saturated in povidone iodine.Use the nondominant hand for the genitalia and the dominant hand for the swabs.Note: use each swab stick for one swipe only.Female patient: with a downward stroke cleanse the right labia minora and discard the swab.Do the same for the left labia minora.With the last swabstick cleanse the middle area between the labia minora.Male patient: cleanse the penis in a circular motion starting at the urethral meatus and working outward.13.Proceed with catheterization in usual manner using the dominant hand.A.When catheter tip has entered bladder, urine will be visible in the drainage tube.B.Insert catheter two more inches and inflate catheter balloon.14.Inflate catheter balloon using entire 10cc of sterile water provided in the prefilled syringe.Note: use of less than 10cc can result in asymmetrically inflated balloon.15.Once inflated, gently pull catheter until the inflated balloon is snug against the bladder neck.16.Secure the foley catheter to the patient use the statlock® foley stabilization device if provided (see statlock® foley stabilization device ifu).Note: please make sure patient is appropriate for use of statlock® stabilization device 17.Position hanger on bed rail at the foot of the bed.Note: exercise care to keep bag off the floor.18.Use green sheeting clip to secure drainage tube to the sheet.Make sure tube is not kinked.19.Indicate time and date of catheter insertion on provided labels.Place designated labels on patient chart and drainage system.20.Document procedure according to hospital protocol." h11: section a through f - the information provided 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 : the device was not returned.
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