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

Model Number	0167L16
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.
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 inconclusive due to an incorrect sample returned.An eggshell white catheter was returned showing a small bend on the catheter balloon.0167l16 is an amber three way irrigation catheter that does not have the eggshell white color.As the reported event stated that all of the catheters came from the same batch, the reported event cannot be confirmed.In addition as the bend was on the catheter balloon and the event stated that it was noticed upon removal, as this can occur due to deflation technique once the balloon was already deflated, the photo may not be indicative of a product failure.A potential root cause could be due to user oversight.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.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.".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
• 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: 9871082
• Report Number: 1018233-2020-02036
• Device Sequence Number: 14047790
• 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): 06/24/2020

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: 06/04/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1