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

Model Number	265720
Health Effect - Clinical Code	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.The information provided by bard 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 bard.
Event or Problem Description
It was reported that the balloon of the catheter would not inflate.The water that was inserted into the balloon was found leaking from the y-connector.
Additional Manufacturer Narrative
Received 1 foley catheter for evaluation.The reported event was confirmed as cause unknown.The sample was inflated with water and observed water leaking from the joint between the inflation funnel and drainage funnel.The sample was visually examined and observed to have a tear at the bifurcation point.The tear was examined under a microscope and noted to be long and rough.Per the functional testing, the site was treated with congo red, a substance that indicates the presence of lubricious coating, and found that the coating was not present inside the tear.The tear was created post lubricious coating.A microscopic examination of the tear looked like it was caused by a sharp object from the outside.The exact cause of sample condition could not be determined and could not be assigned as 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 state the following: "caution: this product contains natural rubber latex which may cause allergic reactions.Pk6194321 4/03 rev.0 sterile unless package is opened or damaged.Do not use if package is opened or damaged.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon burst." (b)(4).
Event or Problem Description
It was reported that the balloon of the catheter would not inflate.The water that was inserted into the balloon was found leaking from the y-connector.

• Brand Name: BARD® FOLEY CATHETER SILICONE COATED
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6893506
• Report Number: 1018233-2017-04977
• Device Sequence Number: 10964948
• Product Code: EZC
• UDI-Device Identifier: 00801741039614
• UDI-Public: (01)00801741039614
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2018

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: Lay User/Patient
• Device Expiration Date: 11/28/2021
• Device Model Number: 265720
• Device Catalogue Number: 265720
• Device Lot Number: 6NK7077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1