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

Model Number 0165SI18

Device Problems Inflation Problem (1310); Failure to Infuse (2340)

Patient Problems Swelling (2091); No Consequences Or Impact To Patient (2199)

Event Date 03/18/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the catheter balloon was difficult to inflate, as the balloon resisted inflation and the funnel part swelled instead.

Manufacturer Narrative

The reported event was unconfirmed since the problem could not be reproduced.The evaluation noted that the catheter could be inflated without difficulty.The catheter was dissected and no conditions were found that could contribute to the reported problem.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: precautions for use: when resistance is encountered in inserting catheter, stop the procedure and remove the catheter.When deflating balloon, do not aspirate with a syringe.[the inflation lumen for balloon deflation may be occluded by negative pressure, and as a result the catheter cannot be removed.] no substance except sterile water should be used to inflate the balloon.[if contrast medium is used, balloon may burst.If normal saline is used, crystallized salt may occlude the inflation lumen to prevent deflation of the balloon.If air is used, air may escape to cause inadvertent deflation of the balloon so that the catheter may come out prematurely.] do not wipe catheter surface with organic solvents such as alcohol.Do not aspirate urine through drainage funnel wall.Since movement of the body, etc.May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely.When urinary flow cannot be noted, confirm that the catheter is neither occluded nor broken.Avoid force on the connecting parts as they may be accidentally disconnected due to the weight of the drainage bag etc.And may cause urine spill.Do not pull or twist the outlet tube.Also, do not squeeze the drainage bag.[the joint of the drainage bag and the outlet tube may be damaged and urine leakage may occur.] when disposing of urine, observe the following; remove the outlet tube from the housing of the urine drainage bag.Lift the green lever to open with holding the outlet tube.Be careful not to pull the outlet tube when lifting the green lever.When disposal of urine is completed, close the green lever and put the outlet tube into the housing.".

Event Description

It was reported that the catheter balloon was difficult to inflate, as the balloon resisted inflation and the funnel part swelled instead.

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8501973
• MDR Text Key: 141586700
• Report Number: 1018233-2019-01851
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016769
• UDI-Public: (01)00801741016769
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: 0165SI18
• Device Catalogue Number: 0165SI18
• Device Lot Number: 8BF8156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1