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

Model Number	0119SI20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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 the urine leaked from one of the lumens at the top of the 3 way foley catheter.The patient was reportedly using a 2 way catheter in the past, but was sent this one and then started experiencing leakage.Per consult with mss, the 3 way catheter should be for hospital use.
Event or Problem Description
It was reported that the urine leaked from one of the lumens at the top of the 3 way foley catheter.The patient was reportedly using a 2 way catheter in the past, but was sent this one and then started experiencing leakage.Per consult with mss, the 3 way catheter should be for hospital use.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to "funnel design (id oversized)".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.Recommended inflation capacities 3cc balloon: use 5cc sterile water 5cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Catheters should be replaced in accordance with the cdc guideline, "guideline for prevention of catheter-associated urinary tract infection." at the onset or first signs of a urinary tract infection, catheter encrustation, or any other catheterrelated adverse effect, the catheter should be replaced to deflate catheter balloon: gently insert a luer slip 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 permitted by hospital protocol, the valve arm may be severed.If this fails, 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.".

• Brand Name: BARDEX® I.C. SHORT TIP FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9733255
• Report Number: 1018233-2020-01192
• Device Sequence Number: 2871650
• Product Code: MJC
• UDI-Device Identifier: 00801741017247
• UDI-Public: (01)00801741017247
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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: Lay User/Patient
• Device Model Number: 0119SI20
• Device Catalogue Number: 0119SI20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1