MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. FOLEY CATHETER; BARDEX IC FOLEY CATHETER

Model Number	772514
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 a small pinhole was found in the catheter during placement.The hole was located under the orange collar located at the top of the catheter.
Additional Manufacturer Narrative
The reported event was confirmed.The evaluation found a tear at the inflation funnel that had caused water to leak out.The origin of the tear could not be determined.The exact cause of the sample condition could not be determined and could not be assigned a manufacturing related process.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 ointment or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Visually inspect the product for any imperfections or surface deterioration prior to use." correction: d4.
Event or Problem Description
It was reported that a small pinhole was found in the catheter during placement.The hole was located under the orange collar located at the top of the catheter.
Event or Problem Description
It was reported that a small pinhole was found in the catheter during placement.The hole was located under the orange collar located at the top of the catheter.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Common Device Name: BARDEX IC FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8081975
• Report Number: 1018233-2018-05479
• Device Sequence Number: 16204098
• Product Code: MJC
• UDI-Device Identifier: 00801741030444
• UDI-Public: (01)00801741030444
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2019

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: 12/01/2022
• Device Model Number: 772514
• Device Catalogue Number: 0165SI16
• Device Lot Number: 7NE8071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 11/19/2018; 01/07/2019
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 12/01/2018; 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1