MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH FOLEY CATHETER; 3 WAY IRRIGATION FOLEY CATHETER

Model Number	0125RL22
Health Effect - Clinical Code	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.
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
Upon further review, bard/bd has determined that this event is cascading and was reported on a previous record.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.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER
• Common Device Name: 3 WAY IRRIGATION FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10093036
• Report Number: 1018233-2020-03438
• Device Sequence Number: 3573396
• Product Code: KOD
• UDI-Device Identifier: 00801741019166
• UDI-Public: (01)00801741019166(10)
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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 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: 08/19/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1