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

Model Number 119216M

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.

Event Description

It was reported that when pulling the foley catheter, the balloon was deflated by allowing the syringe to free fill on its own.The tip would not come out so they pulled back on the syringe to make sure the balloon was fully deflated.The complainant reported that the tip off the foley catheter still would not pass through the urethra.Foley was reportedly left in place and the doctor was notified and he was able to pull the catheter out but still met some resistance.The doctor reported that he experienced the same issue with the foley catheter being difficult to remove from a patient.The catheter from this incident was placed on (b)(6) 2019.

Manufacturer Narrative

The device was not returned for evaluation.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: ¿1.To deflate catheter balloon: gently insert a luer lock or slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve 2.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 3.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation 4.If the balloon will not deflate and 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 5.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.".

Event Description

It was reported that when pulling the foley catheter, the balloon was deflated by allowing the syringe to free fill on its own.The tip would not come out so they pulled back on the syringe to make sure the balloon was fully deflated.The complainant reported that the tip off the foley catheter still would not pass through the urethra.Foley was reportedly left in place and the doctor was notified and he was able to pull the catheter out but still met some resistance.The doctor reported that he experienced the same issue with the foley catheter being difficult to remove from a patient.The catheter from this incident was placed on (b)(6)2019.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9306351
• MDR Text Key: 179445310
• Report Number: 1018233-2019-07226
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741046308
• UDI-Public: (01)00801741046308
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 119216M
• Device Catalogue Number: 119216M
• Device Lot Number: NGDT2993
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: 12/04/2019
• Supplement Dates FDA Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1