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

Catalog Number	33618
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
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 was not draining well or aspirating while foley catheter balloon was up and patient was concerned per that issue.
Event or Problem Description
It was reported that was not draining well or aspirating while foley catheter balloon was up and patient was concerned per that issue.Per additional information received on 04sep2025, customer highlighted the seriousness of the issue, noting that balloon inflation during foley catheter placement post-radical prostatectomy can obstruct urine outflow, affecting multiple patients.Customer also stated that er visits and catheter replacements due to malfunction qualify as injuries.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation: received 1 foley catheter.Verified material number 33618 and manufacturing lot number ngjz0912.Visual inspection noted that the balloon was inflated upon return.Solution was removed from catheter.The catheter was inflated with 10ml of mbs.Catheter can be inflated and deflated without difficulties.Water was introduced into inflation lumen and no blockage or obstruction was observed.Water was able to flow through the inflation lumen and out to the drainage eye without difficulties.The reported event is unconfirmed therefore a labeling review is not required.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions can be taken at this time.Correction: d,e,f,h.Udi format updated with available product information per gudid.Initial reporter name: (b)(6).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
• 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: 22531710
• Report Number: 1018233-2025-05939
• Device Sequence Number: 7425683
• Product Code: EZL
• UDI-Device Identifier: 00801741020070
• UDI-Public: (01)00801741020070(17)290531(10)NGJZ0912
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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
• Device Lot Number: NGJZ0912
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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