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

Catalog Number	33620
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
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.Udi format updated with available product information per gudid.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 customer informed foley catheter was clogged and malfunctioning of the release of the balloon.Customer also mentioned it was difficult to tell when the balloon was full deflated.Informed it happened 4 cases so far.Twice on the same patient.Customer is looking to return all 6 cases remaining.Customer confirmed all 6 cases have the same lot number.
Additional Manufacturer Narrative
The initial reporter's zip code: (b)(6).The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.The reported event is addressed within the labeling.The reported event is addressed within the labeling as it states, 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, 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 necessary, 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.Valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities: 3cc balloon: use 5ml sterile water.5cc balloon: use 10ml sterile water.15cc balloon: use 20ml sterile water.20cc balloon: use 25ml sterile water.30cc balloon: use 35ml sterile water.40cc balloon: use 45ml sterile water.75cc balloon: use 80ml sterile water.Do not exceed recommended capacities.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Correction: d: udi format updated with available product information per gudid.H11: sections 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 customer informed foley catheter was clogged and malfunctioning of the release of the balloon.Customer also mentioned it was difficult to tell when the balloon was full deflated.Informed it happened 4 cases so far.Twice on the same patient.Customer is looking to return all 6 cases remaining.Customer confirmed all 6 cases have the same lot number.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23065411
• Report Number: 1018233-2025-08180
• Device Sequence Number: 15919197
• Product Code: EZL
• UDI-Device Identifier: 00801741020087
• UDI-Public: (01)00801741020087(11)250322(17)290131(10)NGKN4038
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: 33620
• Device Lot Number: NGKN4038
• 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: 09/10/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2025
• 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