MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD FOLEY TRAY WITH LUBRI-SIL ALL-SILICONE FOLEY CATHETER

Model Number	907316
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the foley catheter kept falling out.The user inquired about filling the balloon with more than 10cc of water.Mss advised that bd did not recommend over or under inflating as this could result in asymmetrical balloons, which could deflect the catheter tip to one side.Also, advised that deflation could cause occlusion of drainage eyes, irritate bladder wall, and potentially lead to bladder spasms.Mss stated that the inflation guidelines were attached as a reference and suggested to verify catheter positioning and offered catheter with 30cc balloon as options.
Event or Problem Description
It was reported that the foley catheter kept falling out.The user inquired about filling the balloon with more than 10 cc of water.Mss advised that bd did not recommend over or under inflating as this could result in asymmetrical balloons which could deflect the catheter tip to one side.Also advised that the deflation could cause the occlusion of drainage eyes irritate the bladder wall and potentially lead to bladder spasms.Mss stated that the inflation guidelines were attached as a reference and suggested verifying the catheter positioning and offered the catheter with 30 cc balloon as an option.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to tooling damaged (core pins).It was unknown whether the device had met specifications.The product was used for the treatment purposes.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: "warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst.Directions for use: 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 under pad 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 syringe.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 over penetrate) and depress plunger.Instill entire amount of sterile water (10cc).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: 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, reseat 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." correction: e, h.H11: section a through f - 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.H3 other text : the device was not returned.

• Brand Name: BARD FOLEY TRAY WITH LUBRI-SIL ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11322391
• Report Number: 1018233-2021-00478
• Device Sequence Number: 3335043
• Product Code: EZL
• UDI-Device Identifier: 00801741033063
• UDI-Public: (01)00801741033063
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Model Number: 907316
• Device Catalogue Number: 907316
• Device Lot Number: NGEW4192
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other