MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® HEMATURIA COUDE FOLEY CATHETER; HEMATURIA 2 WAY COUDE

Model Number	2556H22
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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.The device was not returned.
Event or Problem Description
It was reported that the catheter was clogged and did not allow all of the urine to flow out to the bag.The patient stated that the drain bag was changed every four weeks.No medical intervention reported.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential root cause of the reported event could be biological deposits in the drainage lumen due to which the drainage lumen was blocked, resulting in stoppage of urine flow into the bag.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "(3) be careful that the catheter is not exposed to ointments, contrast medium or oil based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.]" h11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the catheter was clogged and did not allow all of the urine to flow out to the bag.The patient stated that the drain bag was changed every four weeks.No medical intervention reported.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that the catheter was clogged and did not allow all of the urine to flow out to the bag.The patient stated that the drain bag was changed every four weeks.No medical intervention reported.

• Brand Name: BARDEX® LUBRICATH® HEMATURIA COUDE FOLEY CATHETER
• Common Device Name: HEMATURIA 2 WAY COUDE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8418585
• Report Number: 1018233-2019-01280
• Device Sequence Number: 11323294
• Product Code: KOD
• UDI-Device Identifier: 00801741025129
• UDI-Public: (01)00801741025129
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2019

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: 08/31/2022
• Device Model Number: 2556H22
• Device Catalogue Number: 2556H22
• Device Lot Number: NGCP0361
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2019
• Supplement Date Received by Manufacturer: 02/23/2019; 05/10/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 03/19/2019; 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1