MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® CENTER ENTRY FOLEY TRAY WITH BARDEX® ALL SILICONE FOLEY CATHETER; SILICONE TRAY

Model Number 897418

Device Problems Restricted Flow rate (1248); Nonstandard Device (1420)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that there was a "flap" (extra piece of plastic) in the bulb of the inlet tube on the drain bag that had to be pushed in in-order for the urine to flow and was causing a restricted flowrate.No medical intervention was required.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿does not provide adequate strain relief¿ with a potential root cause of "tubing wall thickness does not meet specification (wall is too thin)".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: ¿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 csr wrap to form sterile field and place underpad beneath patient, plastic side down.2.Put on cuffed gloves and position drape on patient.3.Pour cleansing solution onto three prep balls.4.Open catheter lubricating jelly.5.Remove top tray and open plastic pouch surrounding catheter.6.Lubricate catheter.7.Prepare patient with saturated prep balls.Dry patient with remaining 2 prep balls.8.Proceed with catheterization in usual manner.To inflate catheter, simply insert tip of water-filled syringe gently into valve (do not overpenetrate) and depress plunger.Instill entire amount of sterile water.9.Position hanger on bedside rail near the foot of the bed and use sheeting clip to secure drainage tube to draw sheet.10.To empty bag: a.Remove outlet tube from housing; gently squeeze connector arms and pull tube from housing.B.Release clamp and empty bag.C.After emptying, reclamp outlet tube and slide connector into housing until connector arms engage.11.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, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the 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.

Event Description

It was reported that there was a "flap" (extra piece of plastic) in the bulb of the inlet tube on the drain bag that had to be pushed in in-order for the urine to flow and was causing a restricted flowrate.No medical intervention was required.

• Brand Name: BARD® CENTER ENTRY FOLEY TRAY WITH BARDEX® ALL SILICONE FOLEY CATHETER
• Type of Device: SILICONE TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9194261
• MDR Text Key: 168029864
• Report Number: 1018233-2019-06506
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741020308
• UDI-Public: (01)00801741020308
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other,user facili
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 897418
• Device Catalogue Number: 897418
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 10/16/2019
• Supplement Dates FDA Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1