MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® HEMATURIA COUDE FOLEY CATHETER

Model Number	2556H22
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
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 the foley catheters were clogging.Also stated that the most recent one that the patient had in might be a week was already too clogged to drain or irrigate and the patient had replaced it.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The device did not fail to meet relevant specifications.The product was used for treatment purposes.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.The device was returned for evaluation.A dhr review is not required as the event is unconfirmed.However, a review was completed before the event was unconfirmed.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.As the reported event is unconfirmed a risk review and labeling review is not required.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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the foley catheters were clogging.Also stated that the most recent one that the patient had in might be a week was already too clogged to drain or irrigate and the patient had replaced it.

• Brand Name: BARDEX® LUBRICATH® HEMATURIA COUDE 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: 12054778
• Report Number: 1018233-2021-03762
• Device Sequence Number: 11674537
• Product Code: KOD
• UDI-Device Identifier: 00801741025129
• UDI-Public: (01)00801741025129
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• 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): 02/07/2022

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: 10/31/2024
• Device Model Number: 2556H22
• Device Catalogue Number: 2556H22
• Device Lot Number: NGER3465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2020
• 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