MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® SILASTIC® FOLEY CATHETER 5CC BALLOON

Catalog Number	33618
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foley catheters would not drain the patient had to go to the hospital to get it replaced.Per additional information received via email on 07oct2025, it was reported that the catheter was removed.Catheter (supra pubic) was placed on (b)(6) 2025.It worked on friday, however on saturday it would not drain.Customer went to the emergency room that afternoon and they did some troubleshooting.They tried flushing and other stuff, but nothing changed the problem.Customer provided them with an other catheter of a different lot number and they replaced it.Everything worked fine after that.Customer would like to note that this was the second catheter from the same lot number that failed in the same manner.Customer had purchased 20 of these catheters from buymedical.Com.The remaining catheters were returned to them and my money was refunded for the returned un- used ones.Customer noted the that lot number was manufactured in malasya and the ones i had no problem with were made in the usa.They exclusively use the bard silastic catheter.The problem they have now is where to purchase them and not have the same issue.
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 foley catheters would not drain the patient had to go to the hospital to get it replaced.Per additional information received via email on 07oct2025, it was reported that the catheter was removed.Catheter (supra pubic) was placed on (b)(6) 2025.It worked on friday, however on saturday it would not drain.Customer went to the emergency room that afternoon and they did some troubleshooting.They tried flushing and other stuff, but nothing changed the problem.Customer provided them with another catheter of a different lot number and they replaced it.Everything worked fine after that.Customer would like to note that this was the second catheter from the same lot number that failed in the same manner.Customer had purchased 20 of these catheters from buymedical.Com.The remaining catheters were returned to them and my money was refunded for the returned un- used ones.Customer noted that lot number was manufactured in malasya and the ones i had no problem with were made in the usa.They exclusively use the bard silastic catheter.The problem they have now is where to purchase them and not have the same issue.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.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 due to incorrect eye size - undersized.A review of the device labeling have been conducted for investigation purposes and was found adequate.The dhr review could not be performed without a lot number.Therefore, no additional action is required at this time.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® SILASTIC® FOLEY CATHETER 5CC BALLOON
• 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, GA 30014 ; 7707846100
• MDR Report Key: 23289775
• Report Number: 1018233-2025-09131
• Device Sequence Number: 20213774
• Product Code: EZL
• UDI-Device Identifier: 00801741020070
• UDI-Public: (01)00801741020070
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K951103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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: 33618
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/11/2025
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 107 KG