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

Model Number	0168L18
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2019
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 balloon damage was found during pretest.Per additional information received via email on 13 december 2019 from ibc representative, there were no visible defects on the catheter.
Additional Manufacturer Narrative
The reported event was unconfirmed.An amber lubricath catheter was returned without its original packaging.No balloon damage was found.The catheter was attempted to be inflated with 10 ccs of air using 10 cc leur lock syringe and the inflation funnel inflated.The catheter was also attempted to be inflated with 10 ccs with water with the same results.A device history record review was not required per the investigation.The instructions for use were found adequate and state the following: "warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst.".The user guide currently contains instruction that would assist in preventing potential user related causes of reported issue." correction: d4.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 balloon damage was found during pretest.Per additional information received via email on 13 december 2019 from ibc representative, there were no visible defects on the catheter.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP
• Common Device Name: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9530501
• Report Number: 1018233-2019-08320
• Device Sequence Number: 319485
• Product Code: EZC
• UDI-Device Identifier: 00801741017834
• UDI-Public: (01)00801741017834
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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: 12/31/2022
• Device Model Number: 0168L18
• Device Catalogue Number: 0168L18
• Device Lot Number: MCCS5188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1