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

Model Number	0134L18
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)
Date of Event	06/28/2019
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 water leaked from the shaft of the catheter.Allegedly, there was a crack on the shaft.
Additional Manufacturer Narrative
The reported event was unconfirmed.A latex three way was returned.The sample was returned with paper on the shaft; that appeared to be attached to the catheter with adhesive.The paper was removed and the catheter tip was placed in the outlet tube of the house leg bag.Water flowed through the irrigation funnel and drainage funnel but not out of the catheter shaft.The catheter was inflated with 35 ccs of water using a 10 cc leur lock syringe.The chatter inflated with no issues and no leaks were seen from the catheter shaft.The paper was removed and catheter tip was placed in the outlet tube of the in house of the in house leg bag.Water flowed through the irrigation funnel and drainage funnel but not out of the catheter shaft.The catheter was inflated with 35 ccs of water using a 10 cc leur lock syringe.The catheter inflated with no issues and no leaks were seen from the catheter shaft.The sample was obtained to be checked for cracks.No cracks were noted.This product would passed based on the procedure.Based on the event description, it is unknown if the product was used for treatment assuming the product was used according to its intended use.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: "on catheter, do not use ointments or lubricants having petrolatum base.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".
Event or Problem Description
It was reported that water leaked from the shaft of the catheter.Allegedly, there was a crack on the shaft.

• Brand Name: BARDEX®LUBRICATH® FOLEY CATHETER ALCOCK MODEL
• Common Device Name: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8798823
• Report Number: 1018233-2019-03971
• Device Sequence Number: 2693864
• Product Code: KOD
• UDI-Device Identifier: 00801741018756
• UDI-Public: (01)00801741018756
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K922431
• 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): 09/12/2019

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: 02/05/2023
• Device Model Number: 0134L18
• Device Catalogue Number: 0134L18
• Device Lot Number: MCCN6048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1