MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER

Model Number	A319516A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
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, after insertion, a pin hole size leak was noted in the foley catheter near the location of the bifurcation.This resulted in the need to remove the catheter and caused the patient pain.No medical intervention was required.After evaluation of the sample, it was found that there was no balloon deflation or leaks from the inflation lumen.However, there was a leak from a hole in the drainage lumen.
Event or Problem Description
It was reported that, after insertion, a pin hole size leak was noted in the foley catheter near the location of the bifurcation.This resulted in the need to remove the catheter and caused the patient pain.No medical intervention was required.Following evaluation of the sample, it was found that there was no balloon deflation or leaks from the inflation lumen.However, there was a leak from a hole in the drainage lumen.
Additional Manufacturer Narrative
The reported event is confirmed as a manufacturing related issue due to a hole less than 0.5" from the funnel.Visual evaluation of the returned sample noted one opened, temperature sensing foley catheter with no obvious defects.The catheter balloon was inflated with 10 ml of methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water) without issue to 60:40 concentricity.The catheters were allowed to rest for 30 minutes, and deflated all 10ml.When the catheter shaft was flushed with the methylene blue solution, the solution leaked from a 0.1105" hole above the drainage lumen 0.4255" from the trifurcation area.The active length of the catheter balloon was measured (0.7050") and found to be within specification (0.6"-0.9").The catheter was confirmed to be 14fr.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: ¿warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage silicone and may cause the balloon to burst.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 catheter-related adverse effect, the catheter should be replaced.Caution: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone balloon foley catheters.Valve type: use luer slip syringe.Do not use needle.With bard® hydrogel and bacti-guard®* silver alloy coating warning: this product should never be connected to the temperature monitor or connected to a cable during an mri procedure.Failure to follow this guideline may result in serious injury to the patient.It is important to closely follow these specific conditions that have been determined to permit the examination to be conducted safely.Any deviation may result in a serious injury to the patient.".

• Brand Name: BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE 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: 8213730
• Report Number: 1018233-2019-00067
• Device Sequence Number: 1710396
• Product Code: MJC
• UDI-Device Identifier: 00801741100338
• UDI-Public: (01)00801741100338
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2019

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: 07/28/2021
• Device Model Number: A319516A
• Device Catalogue Number: 119316
• Device Lot Number: NGAR2640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1