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

Model Number 119314

Device Problems Filling Problem (1233); Failure to Infuse (2340); Improper Flow or Infusion (2954)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2019

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 it was difficult to inject the sterilized water in to the balloon during pretest, also it was difficult to drain the water.

Manufacturer Narrative

The reported event was unconfirmed since the reported failure could not be reproduced.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley with an attached sample port connector and cut portion of inlet tubing.Visual inspection of the catheter surface noted no obvious visible defects.The catheter balloon was inflated with 10ml of methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water) and balloon concentricity was observed to be 60:40.The balloon rested for 30 minutes without leaks and passively deflated without issue, returning 10ml of solution with no cuffing noted.Active length of the catheter balloon was measured (0.7805") 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: "5) to deflate and remove the balloon, attach a needleless syringe to let sterile water in the balloon come out spontaneously through balloon deflation without aspiration.After balloon deflation, withdraw the catheter slowly while confirming that no abnormal resistance is encountered.1.Precautions for use (exercise caution when using the device in the following patients) ·exercise caution when using the device in patients with high urinary calcium levels as encrustation on the balloon surface, catheter occlusion or damage may occur.2.Important precautions ·read all instructions for use prior to use and follow them.·this product is a medical device for qualified physicians, and should not be used for any other purpose.·this product is a disposable, supplied sterile.If package is opened or expiration date has passed, do not use.Do not resterilize.·ensure that all the components are contained in the tray kit.·for instructions regarding other medical equipment and/or medication used in conjunction, refer to the appropriate manufacturer ifus.·do not pull the catheter hard.The catheter including a balloon may be damaged or the bladder/urethral mucous membrane may be injured.·do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.Catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.·when abnormal resistance is encountered in inserting catheter, do not use excessive force, and remove the catheter to find out the cause of difficulty in insertion.·do not penetrate the ez-lok® sampling port with a needle.·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 excessive 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.·to inflate or deflate the balloon, use a luer tip (needleless) syringe.In deflate the balloon, do not aspirate or manually accelerate the deflation of the balloon.If difficult to come out the water spontaneously, refer to ¿troubleshooting¿ as follows. ·do not stretch this catheter as dislodgement of lead wire as temperature probe may cause improper temperature measurement.·when endoelectric surgery is performed, care should be taken to prevent burns in the local tissue.·do not wet the lead wire and the junction with relay cable.·this catheter is compatible only with monitors requiring ysi 400-series type temperature probes.".

Event Description

It was reported that it was difficult to inject the sterilized water in to the balloon during pretest, also it was difficult to drain the water.

• Brand Name: BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8311462
• MDR Text Key: 135692172
• Report Number: 1018233-2019-00672
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741039843
• UDI-Public: (01)00801741039843
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: 119314
• Device Catalogue Number: 119314
• Device Lot Number: NGCN4701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1