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

Model Number	0196L18
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2019
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 the catheter fell out of the patient the next day after placement.Per additional information received via email on 18 september 2019 from ibc representative, there was no damaged to the catheter.Per sample evaluation, the balloon was found to be asymmetric.
Event or Problem Description
It was reported that the catheter fell out of the patient the next day after placement.Per additional information received via email on 18 september 2019 from ibc representative, there was no damaged to the catheter.Per sample evaluation, the balloon was found to be asymmetric.
Additional Manufacturer Narrative
The reported event was confirmed.A lubricath red rubber catheter was returned.The catheter was inflated with 10 ccs using a 10 cc leur lock syringe.The balloon appeared to be inflated.Water was found leaking from around the inflation valve.On closure examination, it was found that there was a small pinhole on the inflation funnel near the inflation valve.The root case of the reported event was due to an operator error during the valve and cap and inspection procedure.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." this instruction would be helpful to prevent the use of a defective catheter.".

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUNCILL 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: 9142083
• Report Number: 1018233-2019-06106
• Device Sequence Number: 19394091
• Product Code: EZC
• UDI-Device Identifier: 00801741017933
• UDI-Public: (01)00801741017933
• 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): 11/07/2019

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: 06/14/2021
• Device Model Number: 0196L18
• Device Catalogue Number: 0196L18
• Device Lot Number: MCAT4983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1