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

Catalog Number	0166SI16
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
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, at the catheter tip that went into bladder it have 2 islets to allow the fluid to go into the foley catheter.That was right up at the tip of the catheter.It was about roughly 5 millimetres from the end and has a slit of about 5 millimetres either side of that.Then blow couple of ml, into the balloon and when the balloon blown up, the catheter tip's only about a centimetre long that sticks out the end, which in turn stop it from going into the wall of your catheter and blocking it up.The islet, the fluid's supposed to come at the bottom & at the top of the chip.One's right up at the end of the chip, and the other one's about another centimetre down the side.Therefore, the balloon then became further down the tip.So the tips inside the bladder was flopping around of about 4 centimetres long, which in turn just crashes into the wall of bladder and blocks up, and it got dysreflexia and caused the chronic dysreflexia, which turn raises customer's blood pressure to about 230, which in turn into a heart failure situation.So patient could not use these catheters.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: b, f, h.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, at the catheter tip that went into bladder it have 2 islets to allow the fluid to go into the foley catheter.That was right up at the tip of the catheter.It was about roughly 5 millimetres from the end and has a slit of about 5 millimetres either side of that.Then blow couple of ml, into the balloon and when the balloon blown up, the catheter tip's only about a centimetre long that sticks out the end, which in turn stop it from going into the wall of your catheter and blocking it up.The islet, the fluid's supposed to come at the bottom & at the top of the chip.One's right up at the end of the chip, and the other one's about another centimetre down the side.Therefore, the balloon then became further down the tip.So the tips inside the bladder was flopping around of about 4 centimetres long, which in turn just crashes into the wall of bladder and blocks up, and it got dysreflexia and caused the chronic dysreflexia, which turn raises customer's blood pressure to about 230, which in turn into a heart failure situation.So patient could not use these catheters.Per follow up information received via ibc on 03dec2025, stated that clinical intervention was reported.
Event or Problem Description
It was reported that, at the catheter tip that went into bladder it have 2 islets to allow the fluid to go into the foley catheter.That was right up at the the tip of the catheter.It was about roughly 5 millimetres from the end and has a slit of about 5 millimetres either side of that.Then blow couple of ml, into the balloon and when the balloon blown up, the catheter tip's only about a centimetre long that sticks out the end, which in turn stop it from going into the wall of your catheter and blocking it up.The islet, the the fluid's supposed to come at the bottom & at the top of the chip.One's right up at the end of the chip, and the other one's about another centimetre down the side.Therefore, the balloon then became further down the tip.So the tips inside the bladder was flopping around of about 4 centimetres long, which in turn just crashes into the wall of bladder and blocks up, and it got dysreflexia and caused the chronic dysreflexia, which turn raises customer's blood pressure to about 230, which in turn into a heart failure situation.So patient could not use these catheters.Per follow up information received via ibc on 03dec2025, stated that clinical intervention was reported.
Additional Manufacturer Narrative
The reported event is considered inconclusive due to the inadequate sample condition.Received (2) photo samples.Visual evaluation of the returned two photo sample noted 1 opened, used latex foley.Visual inspection of the first photo sample shows a close up view of the foley where the statlock lock part is lifting from the base.The second photo shows another instance where the statlock lock part is lifting from the base.Functional testing was not possible based solely on these photos.The catheter balloon was not observed in these photos.Therefore, the reported event is considered inconclusive due to the inadequate sample condition.The labeling is found to be adequate.A review of the device history record could not be performed since the lot number provided was invalid.Based on the results of the investigation, no additional actions can be taken at this time.Corrections: d, h.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.

• 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 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: 23697036
• Report Number: 1018233-2025-10654
• Device Sequence Number: 15721354
• Product Code: MJC
• UDI-Device Identifier: 00801741016844
• UDI-Public: (01)00801741016844
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2026

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: 0166SI16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 12/03/2025; 05/11/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/04/2025; 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; Required Intervention
• Patient Sex: Unknown