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

Catalog Number	802516
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer has been using them for years and noticed a huge change in the catheters.They stated the ones manufactured in mexico are the ones they used to receiving and do not harm or fail him like the current ones which was shipped manufactured out of malaysia.Bard 802516 manufactured in mexico lot# nghx1394 is the good one and is bright red in color with less than 1% failure rate.Bard 802516 manufactured in malaysia lot# ngjn2972 was failing at 10+% of the time causing they to tear and bleed.These are no longer a bright red but now come in a bright or dark orange and causing more harm than good.No medical intervention was provided.Per follow up via email on 19sep2024, it was reported that the product was used on the patient and they have used the same catheter for years and used with lubricating jelly applied prior to insertion.The patient has experienced tearing, bleeding, and discomfort each time these catheters have failed.Patient did not specify if medical intervention was needed, however, due to the injuries, they were not able to self-catheter 6 times per day as required for his medically necessary condition for which they need these catheters.Hospital staff has attempted to see if they can get them a different lot number of the same item and offer alternatives.Patient was no longer comfortable with using any catheters made in malaysia as the materials sourced and used are ineffective, causing this issue.They experienced a 10%+ failure or more with the last several orders of the ones manufactured in malaysia.All of the ones manufactured in mexico have been bright red in appearance and more pliable.Patient had less than 1% failure rate in all of the years when they used them.The ones manufactured in malaysia are a dull orange, not as pliable for use and the materials are rougher on the urethra itself or are not able to empty the bladder.They also stated catheter with the ones made in malaysia pulled blood out and not urine.
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 customer has been using them for years and noticed a huge change in the catheters.They stated the ones manufactured in mexico are the ones they used to receiving and do not harm or fail them like the current ones which was shipped manufactured out of malaysia.Bard 802516 manufactured in mexico lot#: nghx1394 is the good one and was bright red in color with less than 1% failure rate.Bard 802516 manufactured in malaysia lot#: ngjn2972 was failing at 10+% of the time causing they to tear and bleed.These were no longer a bright red but now come in a bright or dark orange and causing more harm than good.No medical intervention was provided.Per follow up via email on 19sep2024, it was reported that the product was used on the patient and they have used the same catheter for years and used with lubricating jelly applied prior to insertion.The patient has experienced tearing, bleeding, and discomfort each time these catheters have failed.Patient did not specify if medical intervention was needed, however, due to the injuries, they were not able to self-catheter 6 times per day as required for their medically necessary condition for which they need these catheters.Hospital staff has attempted to see if they can get them a different lot number of the same item and offer alternatives.Patient was no longer comfortable with using any catheters made in malaysia as the materials sourced and used were ineffective, causing this issue.They experienced a 10%+ failure or more with the last several orders of the ones manufactured in malaysia.All of the ones manufactured in mexico have been bright red in appearance and more pliable.Patient had less than 1% failure rate in all of the years when they used them.The ones manufactured in malaysia are a dull orange, not as pliable for use and the materials are rougher on the urethra itself or are not able to empty the bladder.They also stated catheter with the ones made in malaysia pulled blood out and not urine.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample 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 rough surface, insertion difficulty due to rough drainage eye.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.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: 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: 20397996
• Report Number: 1018233-2024-06347
• Device Sequence Number: 19670888
• Product Code: KOD
• UDI-Device Identifier: 00801741039058
• UDI-Public: (01)00801741039058(11)240301(17)280630(10)NGJN2972
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 802516
• Device Lot Number: NGJN2972
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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