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

Model Number	33624
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/11/2021
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.
Event or Problem Description
It was reported that patient indicated the urinary catheter was thicker than the previous ones they had used.Also stated that patient regularly use 24fr measurement.This urinary probe caused discomfort when inserting the probe into the urinary meatus.
Event or Problem Description
It was reported that patient indicated the urinary catheter was thicker than the previous ones they had used.Also stated that patient regularly use 24fr measurement.This urinary probe caused discomfort when inserting the probe into the urinary meatus.
Additional Manufacturer Narrative
The reported event was inconclusive due to poor sample condition.A photo sample of a green foley catheter was returned.No visual defects were noted.Unable to determine the catheters french size from the photo sample.A potential root cause for this failure could be "operator error".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not required as the reported event is unlikely to be caused by the user.H11: section a through f - the information provided by bard represents all of 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 bard.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11620063
• Report Number: 1018233-2021-01907
• Device Sequence Number: 3280179
• Product Code: EZL
• UDI-Device Identifier: 00801741020100
• UDI-Public: (01)00801741020100
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 11/18/2021

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: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Model Number: 33624
• Device Catalogue Number: 33624
• Device Lot Number: NGDT3395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2019
• 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: Male