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

Model Number	01267522
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2020
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 balloon of the catheter was slightly inflated before use.
Additional Manufacturer Narrative
Per additional information received, bd has determined that this is not a reportable event.
Event or Problem Description
It was reported that the balloon of the catheter was slightly inflated before use.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER CREEVY MODEL
• Common Device Name: IRRIGATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10302744
• Report Number: 1018233-2020-04659
• Device Sequence Number: 3451263
• Product Code: EZC
• UDI-Device Identifier: 00801741018817
• UDI-Public: (01)00801741018817
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K910195
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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: Other
• Device Model Number: 01267522
• Device Catalogue Number: 01267522
• Device Lot Number: NGDY0260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 08/30/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1