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

Model Number	0165SI22
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
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 foley catheter did not deflate.
Event or Problem Description
It was reported that the foley catheter did not deflate.
Additional Manufacturer Narrative
The reported event was unconfirmed as the problem could not be reproduced.The sample was evaluated and no pinch or blockage was observed.The catheter balloon was inflated with 10 ml of water using normal fill technique and the balloon was able to inflate in 11 seconds.The catheter was dissected and did not found anything to contribute to the reported problem.The balloon was deflated and reinflated again with quick fill technique and the balloon was deflated without any difficulty.The deflated balloon did not found anything to contribute to the reported problem.The device did not fail to meet the relevant specifications.A potential root cause for this failure mode could be manufacturing related due to operator error or mechanical error or thin rubberized layer or collapse lumen.However this could not be confirmed.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: "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, reseat 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 5 cc sterile water 5cc balloon: use 10 cc sterile water 30cc balloon: use 35 cc 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 catheter related 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.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 actual/suspected device was inspected.

• 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 30014
• MDR Report Key: 11625146
• Report Number: 1018233-2021-01891
• Device Sequence Number: 16959414
• Product Code: MJC
• UDI-Device Identifier: 00801741016783
• UDI-Public: (01)00801741016783
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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: Health Professional
• Device Expiration Date: 04/28/2025
• Device Model Number: 0165SI22
• Device Catalogue Number: 0165SI22
• Device Lot Number: 0KS030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 07/16/2021
• 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