MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX I.C. FOLEY CATHETER

Model Number	0166SI16
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Burning Sensation (2146); Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient said she experienced worse burning and bruising in her bladder with this catheter than with the last one.It is currently unknown if the patient received intervention.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential root cause could possibly be due to allergies with the latex catheter.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: ¿caution: this product contains natural rubber latex which may cause allergic reactions.Pk7631273 08/2009 to deflate catheter balloon: gently insert a luer slip 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.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.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 recommended inflation capacities 3cc balloon: use 5cc sterile water 5cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Catheters should be replaced in accordance with the cdc guideline, "guideline for prevention of catheter-associated urinary tract infection." at the onset or first signs of a urinary tract infection, catheter encrustation, or any other catheterrelated adverse effect, the catheter should be replaced.Do not exceed recommended capacities.Sterile: unless package is opened or damaged.Do not use if package is opened or damaged.Single use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Visually inspect the product for any imperfections or surface deterioration prior to use.Warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst.".
Event or Problem Description
It was reported that the patient said she experienced worse burning and bruising in her bladder with this catheter than with the last one.It is currently unknown if the patient received intervention.

• Brand Name: BARDEX I.C. FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10025023
• Report Number: 1018233-2020-03029
• Device Sequence Number: 2813537
• Product Code: MJC
• UDI-Device Identifier: 00801741016844
• UDI-Public: (01)00801741016844
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 0166SI16
• Device Catalogue Number: 0166SI16
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 07/10/2020
• 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