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

Catalog Number	33620
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer concern regarding the silastic¿ 2-way, specialty, short round tip catheter (sku# 33620), specifically those from lot# ngkq1139.The customer ordered this product, who used the catheter through a stoma.They reported that they used three catheters from this lot, and none functioned properly.The issue involved urine not draining into the night bag, resulting in urine backing up in the bladder over a period of 2¿3 days.In one instance, they had to visit the emergency room due to painful retention.Upon deflation of the catheter balloon by a nurse, approximately 2000cc of urine rapidly drained into the night bag.The balloon was reinflated with 5cc, but the same issue recurred two days later.The customer suspects a malfunction with the catheter balloon, as urine only drains properly once the balloon was deflated.Advised on next steps for investigating this issue.The customer was concerned about the safety and reliability of this product batch.The customer reported that they ordered a new shipment of silastic¿, 2-way, specialty, short round tip catheters (sku# 33620).Since using the product from lot# ngkq1139, they¿ve experienced issues with urine drainage into the night bag.They shared that they had to visit the emergency room, where a nurse deflated the catheter balloon at which point approximately 2000cc of urine flooded into the night bag.They noted that instead of draining properly through the catheter, urine was backing up, urine go through urethra and causing significant pain.The nurse reinflated the balloon with 5cc, but the same issue occurred again two days later.They suspected a problem with the catheter balloon, as urine backs up in the bladder over 2¿3 days, and once the balloon was deflated, urine drains freely.They didn't have an explanation on why this happened.Customer recommended to check with urologist, and they stated that they were having an appointment and advised to try using a catheter that has different lot# as they explained that they used 3 catheters from lot# ngkq1139 and all didn't work.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.All available udi information is being provided.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
The reported event was unconfirmed because the reported failure could not be reproduced.The product had not caused the reported failure.No root cause could be found because the reported event was not confirmed.The labeling and instructions for use were found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Therefore, no additional action is required at this time.Corrections: d, e, h.Udi format updated with available product information per gudid.H11: sections 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 concern regarding the silastic¿ 2-way, specialty, short round tip catheter (sku# 33620), specifically those from lot# ngkq1139.The customer ordered this product, who used the catheter through a stoma.They reported that they used three catheters from this lot, and none functioned properly.The issue involved urine not draining into the night bag, resulting in urine backing up in the bladder over a period of 2¿3 days.In one instance, they had to visit the emergency room due to painful retention.Upon deflation of the catheter balloon by a nurse, approximately 2000cc of urine rapidly drained into the night bag.The balloon was reinflated with 5cc, but the same issue recurred two days later.The customer suspects a malfunction with the catheter balloon, as urine only drains properly once the balloon was deflated.Advised on next steps for investigating this issue.The customer was concerned about the safety and reliability of this product batch.The customer reported that they ordered a new shipment of silastic¿, 2-way, specialty, short round tip catheters (sku# 33620).Since using the product from lot# ngkq1139, they¿ve experienced issues with urine drainage into the night bag.They shared that they had to visit the emergency room, where a nurse deflated the catheter balloon at which point approximately 2000cc of urine flooded into the night bag.They noted that instead of draining properly through the catheter, urine was backing up, urine go through urethra and causing significant pain.The nurse reinflated the balloon with 5cc, but the same issue occurred again two days later.They suspected a problem with the catheter balloon, as urine backs up in the bladder over 2¿3 days, and once the balloon was deflated, urine drains freely.They didn't have an explanation on why this happened.Customer recommended to check with urologist, and they stated that they were having an appointment and advised to try using a catheter that has different lot# as they explained that they used 3 catheters from lot# ngkq1139 and all didn't work.Per customer via phone on 25sep2025, it was reported that primary care provider stated that the issue was related directly to the catheter.Customer stated they never had an issue within the four years they had used the product and thought it may be a bad batch.

• Brand Name: BARD® SILASTIC® 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, GA 30014 ; 7707846100
• MDR Report Key: 23098447
• Report Number: 1018233-2025-08375
• Device Sequence Number: 18517401
• Product Code: EZL
• UDI-Device Identifier: 00801741020087
• UDI-Public: (01)00801741020087(11)250411(17)290131(10)NGKQ1139
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: CA
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 33620
• Device Lot Number: NGKQ1139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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