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

Catalog Number	0165SI20
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they changed balloon on (b)(6).On (b)(6), the 13th day, while changing a diaper, they discovered that the foley catheter balloon part was broken so, the foley catheter had naturally removed.
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 they changed balloon on july 31st.On august 11th, the 13th day, while changing a diaper, they discovered that the foley catheter balloon part was broken so, the foley catheter had naturally removed.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found that there was no allegation against product.Udi format updated with available product information per gudid.

• 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
• 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: 20128711
• Report Number: 1018233-2024-05441
• Device Sequence Number: 16960297
• Product Code: MJC
• UDI-Device Identifier: 00801741016776
• UDI-Public: (01)00801741016776
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: 0165SI20
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 09/25/2024
• 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