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

Catalog Number 129414M

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

Patient Problems Tissue Damage (2104); Patient Problem/Medical Problem (2688)

Event Date 07/17/2019

Event Type  Injury  

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 it was difficult to deflate the balloon and the user was unable to remove the catheter from patient's body.The catheter was removed by percutaneous puncture.

Event Description

It was reported that it was difficult to deflate the balloon and the user was unable to remove the catheter from patient body.The catheter was removed by percutaneous puncture.

Manufacturer Narrative

The reported event was found inconclusive due to the way the sample was received.She sample was evaluated and no pinch or blockage was observed.Water was able to be introduce into the returned sample.No conditions were found on the sample that could be associated with reported event.Due to poor condition of the returned sample, a complete evaluation could not be performed.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: ¿(1) when resistance is encountered in inserting catheter, stop the procedure and remove the catheter.(2) 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.] (3) 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.] (4) do not wipe catheter surface with organic solvents such as alcohol.(5) do not aspirate urine through drainage funnel wall.(6) since movement of the body, etc.May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely.(7) when urinary flow cannot be noted, confirm that the catheter is neither occluded nor broken.(8) 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.(9) 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.]" 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® I.C. TEMPERATURE SENSING 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: 8898772
• MDR Text Key: 154531550
• Report Number: 1018233-2019-04765
• Device Sequence Number: 1
• Product Code: MJC
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 129414M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Date Manufacturer Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention