MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER; 3-WAY BARDEX FOLEY CATHETER

Model Number	0167L16
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	02/28/2020
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 there were several faulty catheters from the same batch: the eyelets from one of the catheters were not uniformed, the balloon from one catheter inflated on one side, and one of the catheters was found kinked/bent upon removal.Reportedly, all of the events caused unnecessary discomfort and pain to the patients.
Additional Manufacturer Narrative
The reported event was confirmed.A photo sample of an amber lubricath catheter was returned with an asymmetric balloon.However as it is unknown whether the device was correctly inflated the cause of the issue could not be confirmed.A potential root cause could be due to "balloon molding".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.¿ use luer tip syringe to inflate with stated ml of sterile water.Or ¿ for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.To deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 15cc balloon: use 20ml sterile water 20cc balloon: use 25ml sterile water 30cc balloon: use 35ml sterile water 40cc balloon: use 45ml sterile water 75cc balloon: use 80ml sterile water".
Event or Problem Description
It was reported that there were several faulty catheters from the same batch: the eyelets from one of the catheters were not uniformed, the balloon from one catheter inflated on one side, and one of the catheters was found kinked/bent upon removal.Reportedly, all of the events caused unnecessary discomfort and pain to the patients.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: 3-WAY BARDEX FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9871078
• Report Number: 1018233-2020-02035
• Device Sequence Number: 2377869
• Product Code: KOD
• UDI-Device Identifier: 00801741018947
• UDI-Public: (01)00801741018947
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

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: 07/31/2023
• Device Model Number: 0167L16
• Device Catalogue Number: 0167L16
• Device Lot Number: NGCZ2156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1