MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH FOLEY CATHETER COUDE TIP; 5CC COUDE BARDEX LUBRICATH FOLEY CATHETER

Model Number	0168L12
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/30/2020
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 catheter balloon was difficult to inflate during pretest.
Event or Problem Description
It was reported that the catheter balloon was difficult to inflate during pretest.
Additional Manufacturer Narrative
The reported event was confirmed as design-related.An amber lubricath catheter was returned opened without its original packaging.The catheter was attempted to be inflated with 10 ccs of water.The inflation funnel instead was inflated.The catheter had a lighter color near the area where the inflation funnel expanded.The catheter was cut below inflation valve and above the white mark to determine the location of the occlusion or blockage.A slip tip was used to inflate the funnel with no success.The entire funnel was cut off and the slip tip was used to infuse water directly into the inflation lumen, inflating the balloon.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: "-warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst.-valve type: use luer slip tip syringe.Do not use needle.-recommended inflation capacities:5cc balloon: use 10ml sterile water.-visually inspect the product for any imperfections or surface deterioration prior to use." 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.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER COUDE TIP
• Common Device Name: 5CC COUDE BARDEX LUBRICATH FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9992868
• Report Number: 1018233-2020-02791
• Device Sequence Number: 11371761
• Product Code: EZC
• UDI-Device Identifier: 00801741017803
• UDI-Public: (01)00801741017803
• 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): 07/29/2020

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: 08/20/2024
• Device Model Number: 0168L12
• Device Catalogue Number: 0168L12
• Device Lot Number: MCDV3015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1