MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP; COUDE CATHETER

Catalog Number	010112
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sepsis (2067); Urinary Tract Infection (2120)
Date of Event	07/21/2025
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 the user used expired coude catheter and shortly after the use got a urinary tract infection.Coude catheter was expired in 2022 and was used by (b)(6)2025.Representative informed patient that they did not have an expiration extension letter and they did not recommend the use of expired products.They suggested to reach out to health care professional as bd couldn't identify the cause of uti.
Event or Problem Description
It was reported that the user used expired coude catheter and shortly after the use got a urinary tract infection.Coude catheter was expired in 2022 and was used by july 2025.Representative informed patient that they did not have an expiration extension letter and they did not recommend the use of expired products.They suggested to reach out to health care professional as bd couldn't identify the cause of uti.Per follow up information received via phone on 11sep2025, it was reported that the customer stated that he used catheters that he had in possession for 12 or 13 years.He stated after using the catheters he developed a uti.He was in the hospital for a week, became septic, and developed a kidney infection.He has a follow up appt with his urologist tomorrow and they will discuss his surgery.He may possibly not have to use catheters anymore.He did not have a lot or sample as he did throw the old catheters away after instructed by his urologist.No additional information is available.No further follow-up attempts are required.
Additional Manufacturer Narrative
The reported event was confirmed use related as used expired coude catheter.Sample was not available for evaluation.The root cause identified is "device used improperly device used in manner for which not designed or approved for".The labeling is found to be adequate.A dhr review was not required because the investigation was confirmed as use related.No additional action is required at this time.Correction: b,d,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.

• Brand Name: BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP
• Common Device Name: COUDE 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: 22589515
• Report Number: 1018233-2025-06130
• Device Sequence Number: 21129858
• Product Code: KOD
• UDI-Device Identifier: 00801741029851
• UDI-Public: (01)00801741029851(11)180327(17)220831(10)NGCQ0578
• Combination Product (Y/N): N
• 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): 10/13/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 010112
• Device Lot Number: NGCQ0578
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2018
• 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: Hospitalization; Other
• Patient Sex: Unknown