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

Model Number	0165L22
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); 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.
Event or Problem Description
It was reported that the lubricath foley catheter was difficult to remove.The catheter was ultimately removed by being pulled out of the patient.Reportedly when the catheter was removed the balloon was still partially inflated and hard to the touch; sediment was also found in the tubing.There was no reported impact to the patient.
Event or Problem Description
It was reported that the lubricath foley catheter was difficult to remove.The catheter was ultimately removed by being pulled out of the patient.Reportedly when the catheter was removed the balloon was still partially inflated and hard to the touch; sediment was also found in the tubing.There was no reported impact to the patient.
Additional Manufacturer Narrative
The reported event was inconclusive due to the condition of the returned sample.The inflation valve and about six inches of the catheter from the proximal end was returned in a plastic bag.The rest of the catheter including the bifurcation was missing.A 10 cc luer lock syringe was used to flush water through the valve.Water entered and exited the valve with no issues.A 10cc slip tip syringe was inserted into the inflation lumen of the returned part of the catheter.The balloon and deflated with no issues.Because only a portion of the catheter was returned, the reported event could not be unconfirmed.A potential root cause could be due to a "kinked lumen" or a "partially pinched lumen".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: "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: LUBRICATH FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8669914
• Report Number: 1018233-2019-02927
• Device Sequence Number: 18895759
• Product Code: EZC
• UDI-Device Identifier: 00801741017513
• UDI-Public: (01)00801741017513
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2019

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 Model Number: 0165L22
• Device Catalogue Number: 0165L22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1