MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® FOLEY CATHETER SILICONE COATED

Catalog Number	0167V24S
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be user related (example: contact with sharp object)/mechanical failure/operator error.A potential root cause for this failure mode could be due to blister ply (sac tearing) caused by high mechanical stability time of incoming latex.Based on information in the fmea, the risk of this failure is medium.Current controls in place are adequate to mitigate this failure mode.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "caution: this product contains natural rubber latex which may cause allergic reactions.Sterile: unless package has been opened or damaged.Warning: do not use ointments or lubricants having a petroleum base.They will damage latex and may burst balloon.Do not aspirate urine through the drainage funnel wall.Single use only.Do not desterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use 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, 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 an adequately trained professional for assistance, as directed by hospital protocol." this report references a us equivalent device.The us udi equivalent for this product number is used.H11: section a through f - the information provided by bd represents all 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.
Event or Problem Description
It was reported that the water leaked from the balloon area of the foley catheter.Per follow up information received via ibc on 26aug2024, stated that the water balloon did not rupture.

• Brand Name: BARDEX® FOLEY CATHETER SILICONE COATED
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 20126293
• Report Number: 1018233-2024-05372
• Device Sequence Number: 7462258
• Product Code: KOD
• UDI-Device Identifier: 00801741019241
• UDI-Public: (01)00801741019241
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2024

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 Catalogue Number: 0167V24S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown