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

Model Number	087016
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that there was urine leakage from the ports that the ureteral catheters are pulled out of on the foley.The foley was exchanged and one was used on the patient that did not have the ureteral ports.
Event or Problem Description
It was reported that there was urine leakage from the ports that the ureteral catheters are pulled out of on the foley.The foley was exchanged and one was used on the patient that did not have the ureteral ports.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential root cause of the reported event could be incorrect drainage funnel design in terms of oversized id due to which there was a loose fit between the connector and the drainage funnel, resulting in urine leakage and replacement of device.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.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.H3 other text : the device was not returned.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER EDELMAN MODEL
• Common Device Name: LUBRICIOUS COATED EDELMEN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8831518
• Report Number: 1018233-2019-04246
• Device Sequence Number: 16227010
• Product Code: EZC
• UDI-Device Identifier: 00801741039232
• UDI-Public: (01)00801741039232
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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
• Operator of Device: Health Professional
• Device Model Number: 087016
• Device Catalogue Number: 087016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1