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

Catalog Number	802514
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer had paraplegic that has been using the red rubber coude intermittent catheter products for decades also had never had an issue until recently the batches being produced were not safe for use.The customer had injured their urethra due to the new, poorly made catheters on multiple occasions leading to 'urinary tract infection and other issue also had been forced to use older versions of the catheter to avoid these issues.The customer has been used (lot #ngfq4299) was an example of the original good product with a perfectly smooth surface, these seemed to no longer be in production as the package indicates they were made in mexico.Also (batch# #ngjn3051) and (batch# ngjt0667) were examples of the new bad product noticeably brighter in color (batch# ngjn3051, batch# ngjt0667) a bit softer lower quality feel (batch# ngjn3051, batch# ngjt0667), which has some very inconsistent manufacturing errors creating a textured surface and was causing abrasions in the urethra (batch# ngjn3051, batch# ngjt0667).They wanted to bring this to your attention because people were getting hurt.The packaging indicates it was made in malaysia.The texture was so bad on many of these, the customer put on a sterile glove and slide my fingers down the length of the catheter to felt how rough the surface was before using it to avoid injury also have had to throw more away that they have been able to use.The customer had hundreds of catheters and unable to use from the malaysian facility and would be notifying the medical supply distributors of how dangerous these new catheters were to avoid additional injury.It was unknown what medical intervention was provided for the urinary tract infection at this time.
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
Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.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 paraplegic that has been using the red rubber coude intermittent catheter products for decades also had never had an issue until recently the batches being produced were not safe for use.The customer had injured their urethra due to the new, poorly made catheters on multiple occasions leading to 'urinary tract infection and other issue also had been forced to use older versions of the catheter to avoid these issues.The customer has been used (lot #ngfq4299) was an example of the original good product with a perfectly smooth surface, these seemed to no longer be in production as the package indicates they were made in mexico.Also (batch# #ngjn3051) and (batch# ngjt0667) were examples of the new bad product noticeably brighter in color (batch# ngjn3051, batch# ngjt0667) a bit softer lower quality feel (batch# ngjn3051, batch# ngjt0667), which has some very inconsistent manufacturing errors creating a textured surface and was causing abrasions in the urethra (batch# ngjn3051, batch# ngjt0667).They wanted to bring this to your attention because people were getting hurt.The packaging indicates it was made in malaysia.The texture was so bad on many of these, the customer put on a sterile glove and slide my fingers down the length of the catheter to felt how rough the surface was before using it to avoid injury also have had to throw more away that they have been able to use.The customer had hundreds of catheters and unable to use from the malaysian facility and would be notifying the medical supply distributors of how dangerous these new catheters were to avoid additional injury.It was unknown what medical intervention was provided for the urinary tract infection at this time.

• 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_old ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21103033
• Report Number: 1018233-2025-00041
• Device Sequence Number: 15687114
• Product Code: KOD
• UDI-Device Identifier: 00801741039041
• UDI-Public: (01)00801741039041(17)280531(10)NGJT0667
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: Health Professional
• Device Catalogue Number: 802514
• Device Lot Number: NGJT0667
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/26/2025
• 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