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

Model Number	0125RL22
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/06/2020
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 3 way catheter could not be irrigated.Once removed from the patient, the user found that the catheter was missing the irrigation eye hole.
Additional Manufacturer Narrative
The reported event was confirmed, as a manufacturing-related.A red rubber lubricath catheter was returned without its original packaging.The catheter was missing an irrigation eye.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: "visually inspect the product for any imperfections or surface deterioration prior to use".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.
Event or Problem Description
It was reported that the 3 way catheter could not be irrigated.Once removed from the patient, the user found that the catheter was missing the irrigation eye hole.Per investigation results, it was found that a missing irrigation eye prevent irrigation and both the events are cascading.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER
• Common Device Name: LUBRICATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10092840
• Report Number: 1018233-2020-03422
• Device Sequence Number: 3611069
• Product Code: KOD
• UDI-Device Identifier: 00801741019166
• UDI-Public: (01)00801741019166
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2020

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: 07/30/2024
• Device Model Number: 0125RL22
• Device Catalogue Number: 0125RL22
• Device Lot Number: NGDY0272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1