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

Model Number 087016

Device Problems Leak/Splash (1354); Off-Label Use (1494); Use of Device Problem (1670)

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

Event Date 09/03/2019

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 during the investigation, it was found during testing that when there was a leaking problem in the ports.Per ms&s the ureteral catheters, not stents were used in the edelman catheter and the plugs placed into the catheter ports were an off-label use that could potentially deform the catheter.

Event Description

It was reported that during the investigation, it was found during testing that when there was a leaking problem in the ports.Per ms&s the ureteral catheters, not stents were used in the edelman catheter and the plugs placed into the catheter ports were an off-label use that could potentially deform the catheter.

Manufacturer Narrative

The reported event was confirmed as use-related.In-house polyurethane ureteral catheters were placed in the catheter plugs of the returned sample and a 12cc slip tip syringe was used to placed water through each catheter's eye.When water was placed through the blue left ureteral catheter, water was seen leaking through the port connection.When fluid was placed through the red ureteral catheter, water was seen going through the edelman drainage eyes and the blue catheter connection point but not its own.When the process was repeated with different orientations, leakage was still observed.During evaluation, water was seen going through the catheter into the meter bag, therefore there was no evidence of an occlusion.The event description for the related record revealed that instead of using ureteral catheters in the plugged adapters as instructed in the ifu, the nursing staff used stents.Additional information received from moncks quality engineering and ms&s stated that the plugs made by the nurses can deform the catheter.Therefore, usage of plugs and stents are considered off label usage.It is unknown whether the device failed to meet specifications.The device was being used for treatment.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.Place ureteral catheters into desired position.2.Insert edelman catheter into the urethra and inflate the 5cc balloon when catheter is positioned in the bladder.3.Insert the ureteral catheters into the side ports (which are pre-slit for convenience) until the distal ends of the catheters protrude from the drainage lumen of the edelman catheter.4.The excess length of the ureteral catheters can be trimmed off if desired.5.Connect the drainage funnel of the edelman catheter to a urinary drainage bag.Bardex edelman model foley catheter reorder 087016 - 16 fr.087018 - 18 fr.Bard and bardex are registered trademarks of c.R.Bard, inc.Or an affiliate.C.R.Bard, inc.Covington, ga 30014 1-800-526-4455 www.Bardmedical.Com warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Caution: this product contains natural rubber latex which may cause allergic reactions.Suggestions: 1.It may be desirable to tape or tie with o silk ligature, the ureteral catheters to the foley catheter.2.When the ureteral catheters are inserted, label left and right for easy identification." 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® LUBRICATH® FOLEY CATHETER EDELMAN MODEL
• Type of Device: EDELMAN CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9526049
• MDR Text Key: 178785122
• Report Number: 1018233-2019-08272
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741039232
• UDI-Public: (01)00801741039232
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2024
• Device Model Number: 087016
• Device Catalogue Number: 087016
• Device Lot Number: MCDN5208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1