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

Catalog Number	0168SI16
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the just saw an aware 230007 from (b)(6) hospital where a patient came back to the emergency department because the foley ¿fell out¿.Patient returned to the emergency department after indwelling urethral catheter "fell out".On arrival catheter no longer in place.Patient returned home and when getting out of the car reports noticed that his pants were getting wet.See attachments for the condition of foley catheter.They have pictures of the catheter it looks as though the balloon just burst.They also have pictured the packaging and lot number in the form.
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 just saw an aware 230007 from (b)(6) hospital where a patient came back to the ed because the foley ¿fell out¿.Patient returned to the emergency department after indwelling urethral catheter "fell out".On arrival catheter no longer in place.Patient returned home and when getting out of the car reports noticed that his pants were getting wet.See attachments for the condition of foley catheter.They have pictures of the catheter it looks as though the balloon just burst.They also have pictured the packaging and lot number in the form.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Received (4) photo samples.Visual evaluation of the returned four-photo sample noted one opened (without original packaging), used latex foley.Visual inspection of the first video sample showed a close up picture of the labeling which came with the catheter along with the tray number.The second photo shows the tip of the catheter which shoes the balloon has ruptured.The third photo shows another view of the tip of the catheter which shows the balloon has ruptured.The fourth photo shows the labeling insert which came with the product.The reported failure is confirmed cause unknown.A review of the device history record could not be performed since no lot number was provided.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.

• Brand Name: BARDEX® I.C. CARSON MODEL COUDE TIP 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: 23518897
• Report Number: 1018233-2025-10138
• Device Sequence Number: 9955259
• Product Code: MJC
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0168SI16
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 05/05/2026
• 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