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

Catalog Number	802514
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Sharp Edges (4013)
Health Effect - Clinical Codes	Abrasion (1689); Urinary Tract Infection (2120)
Date of Event	12/19/2024
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 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.
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 reported event was inconclusive because no sample was returned was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be drainage eyes rough that can lead patient discomfort.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: indications for use: for urological use only.Single use.Single patient use.Do not reuse do not use if package is open or damaged.Sterilized using ethylene oxide.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Caution: this product contains natural rubber latex which may cause allergic reactions.Warnings: on latex and red rubber catheters, do not use ointments or lubricants having a petroleum base.They will damage latex.Visually inspect the product for any imperfections or surface deterioration prior to use.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristic of the device, which may lead to failure, and/or to injury, illness or death of the patient.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local state and federal laws and regulation.Adverse reactions: urinary tract infection, bleeding from urethra, irritation of the urethra.Instruction for intermittent catheters: 1.Wash your hands thoroughly with soap and water.2.Remove catheter from the pack.3.Position yourself comfortably cleaning the opening of the urethra and surrounding area.4.Gently insert rounded end of catheter into urethra.5.When urine stops flowing, remove catheter from urethra.6.Dispose of catheter in accordance with local rules and regulations.7.Wash your hands.Correction: d 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.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: b, d, e, f, g, 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: BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER
• Common Device Name: URETHRAL 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 30014 ; 7707846100
• MDR Report Key: 21123826
• Report Number: 1018233-2024-08706
• Device Sequence Number: 8682212
• Product Code: KOD
• UDI-Device Identifier: 00801741039041
• UDI-Public: (01)00801741039041(11)240717(17)280531(10)NGJT0667
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,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?: Yes
• 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: 03/19/2025; 03/26/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/25/2025; 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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