MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER; INTERMITTENT CATHETER

Catalog Number	802516
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Codes	Unspecified Infection (1930); Discomfort (2330)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer had been using the simple rubber intermittent catheter for years.The customer has had a higher rate of infections over the past few years.Stiffness was much higher than their previous model.The discomfort level was significantly higher due to the rigid tip.The hydrophilic lubricant was very clever but not as slippery as the self-applied lubricant.Customers did like the sleeve, and they would like a sleeve like the magic 3 go on their previous catheter.The representative advised the customer that their comments were greatly appreciated.It was unknown what medical intervention was reported.
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.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.No actions can be taken at this time since a root cause was not identified.A dhr review is not required as the lot number is unknown.A labeling review was not performed because labeling could not have prevented the reported failure.Correction- e.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 had been using the simple rubber intermittent catheter for years.The customer has had a higher rate of infections over the past few years.Stiffness was much higher than their previous model.The discomfort level was significantly higher due to the rigid tip.The hydrophilic lubricant was very clever but not as slippery as the self-applied lubricant.Customers did like the sleeve, and they would like a sleeve like the magic 3 go on their previous catheter.The representative advised the customer that their comments were greatly appreciated.It was unknown what medical intervention was reported.Per additional information received via phone on 29jan2025, it was reported that it was not a complaint.Customer only called to suggest that a sleeve be put on the red rubber catheter just like the one on the magic3 go.They prefer the red rubber over the magic3 go because the red rubber was not as stiff.

• Brand Name: BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER
• Common Device Name: INTERMITTENT 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 30014 ; 7707846100
• MDR Report Key: 21249185
• Report Number: 1018233-2025-00340
• Device Sequence Number: 8206156
• Product Code: KOD
• UDI-Device Identifier: 00801741039058
• UDI-Public: (01)00801741039058
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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: Lay User/Patient
• Device Catalogue Number: 802516
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 04/03/2025
• 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