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

Model Number	1758SI24
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
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 bulb would not deflate when it was in patient.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample returned for evaluation.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be due to a poor balloon design or inadequate material selection.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: on catheter, do not use ointments or lubricants having petrolatum base.They will damage silicone and may cause the balloon to burst.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.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Caution: do not aspirate the urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.Sterile unless package is opened or damaged.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.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.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe stick in the valve.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.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.Recommended inflation capacities 5 cc balloon: use 10 cc sterile water.30cc balloon: use 35 cc sterile water.Do not exceed recommended capacities." corrections: a, b, e, f.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 or Problem Description
It was reported that the balloon did not deflate when it was in the patient and did not have it any longer.Per follow up on 09apr2021 it was stated that the catheter was not inserted in the patient when the defect was noticed.The customer noted the issue during the pretest the balloon would inflate but did not deflate.

• Brand Name: BARDEX LUBRI-SIL I.C. ALL-SILICONE FOLEY CATHETER
• Common Device Name: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11610148
• Report Number: 1018233-2021-01838
• Device Sequence Number: 17060736
• Product Code: EZL
• UDI-Device Identifier: 00801741025266
• UDI-Public: (01)00801741025266
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2021

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: 08/31/2023
• Device Model Number: 1758SI24
• Device Catalogue Number: 1758SI24
• Device Lot Number: NGDU2585
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 07/13/2021
• 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