MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX I.C. COMPLETE CARE FOLEY TRAY; STATLOCK DEVICE

Catalog Number FOL0102

Device Problem Loss of or Failure to Bond (1068)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the stalock received in one of foley trays was not as sticky as normal and also it kept falling off.

Event Description

It was reported that the stalock received in one of foley trays was not as sticky as normal and also it kept falling off.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to "adhesive chemistry not appropriate for application (poor quick stick characteristics)".It was unknown whether the device had met specifications.The product was used for treatment but it was unknown whether the product had caused the reported failure.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: "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.1.Open outer white wrapping to prepare sterile field and place underpad beneath patient, plastic side down.2.If patient has a catheter in-situ to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, reseat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.Wait at least 30 seconds for deflation.If permitted by local protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance as directed by local protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.3.Put on gloves, cover patient with fenestrated drape with open exposing location where catheter will be inserted, and place the apron on yourself.4.Using the two (2) syringes, marked ¿for cleansing purposes only¿, dispense the water onto three (3) gauze squares.Prepare the patient by wiping down the catheter insertion site with the saturated gauze squares.Dry patient with the remaining two (2) gauze squares.Note: do not use this syringe to inflate the catheter balloon.5.Prepare the lubricating gel syringe by removing the cap from the syringe tip.6.For easing with the insertion of the catheter into the patient dispense the lubricating gel into the urethra (according to local protocol).7 remove top tray and open plastic pouch (sleeve) surrounding the catheter.8.Proceed with catheterisation according to local protocol.To inflate catheter, simply insert tip of sterile water-filled syringe gently into valve (do not overpenetrate) and depress plunger.Instill entire amount of sterile water - 10 ml.9.Attach statlock® foley stabilisation device to the bifurcation (y-shape) of the foley catheter (statlock® foley stabilisation device can be used for up to 7 days) and apply.(refer to the instructions for use provided with the statlock® foley stabilisation device pouch for more details).10.If the procedure pack includes a leg bag, utilise the leg straps provided to secure the leg bag to the patient¿s leg, making sure not to affect circulation or drainage of urine.11.Ensure catheter and drainage bag tubing is kink free and drainage bag is positioned below the bladder to ensure urine is flowing freely.Periodic inspection of this system should be made to ensure that urine is flowing freely.If a standing column of urine is observed, check for correct positioning of bag and then for a physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, further investigation should be taken in line with local protocol" 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.

• Brand Name: BARDEX I.C. COMPLETE CARE FOLEY TRAY
• Type of Device: STATLOCK DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10810240
• MDR Text Key: 215330489
• Report Number: 1018233-2020-20799
• Device Sequence Number: 1
• Product Code: EYJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: FOL0102
• Device Lot Number: JUDZ0909
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other