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

Model Number	087016
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Patient Problem/Medical Problem (2688)
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 the balloon of the edelman foley catheter would not deflate.It is unknown how the balloon was deflated for removal.The patient did experience localized bleeding.No medical intervention reported.
Additional Manufacturer Narrative
The device was not returned for evaluation.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: ¿directions for use: 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." 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.
Event or Problem Description
It was reported that the balloon of the edelman foley catheter would not deflate.It was unknown how the balloon was deflated for removal.The patient did experience localized bleeding.No medical intervention reported.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER EDELMAN MODEL
• Common Device Name: EDELMAN FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8833555
• Report Number: 1018233-2019-04257
• Device Sequence Number: 13983115
• Product Code: EZC
• UDI-Device Identifier: 00801741039232
• UDI-Public: (01)00801741039232
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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 Expiration Date: 10/31/2022
• Device Model Number: 087016
• Device Catalogue Number: 087016
• Device Lot Number: NGCV3244
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1