MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX®LUBRICATH® FOLEY CATHETER ALCOCK MODEL; FOLEY CATHETER (LATEX)

Model Number	0134L22
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2019
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 after placing the catheter, irrigation was attempted, however water could not be injected into the irrigation port.
Additional Manufacturer Narrative
The reported event was confirmed.A three way lubricath foley catheter was returned for evaluation.A slip tip syringe was used.No water was able to be flushed.The irrigation funnel was cut off.A slip tip syringe was used, water flowed through, and no occlusion was found in the irrigation funnel.A slip tip syringe was inserted into the irrigation lumen, water flowed through, and no occlusion was found in the irrigation lumen.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: "sterile unless package is opened or damaged.Warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip tip syringe.Do not use needle.".
Event or Problem Description
It was reported that after placing the catheter, irrigation was attempted, however water could not be injected into the irrigation port.

• Brand Name: BARDEX®LUBRICATH® FOLEY CATHETER ALCOCK MODEL
• Common Device Name: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8375583
• Report Number: 1018233-2019-01058
• Device Sequence Number: 1104693
• Product Code: KOD
• UDI-Device Identifier: 00801741018770
• UDI-Public: (01)00801741018770
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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: Health Professional
• Device Expiration Date: 09/26/2022
• Device Model Number: 0134L22
• Device Catalogue Number: 0134L22
• Device Lot Number: MCBW4884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1