MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER CREEVY MODEL; 3 WAY IRRIGATION CATHETER

Model Number	01267522
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2020
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.
Event or Problem Description
It was reported that the balloon could not be fully deflated.Per additional information from the ibc via email 13-feb-2020; the water was difficult to remove.The user tried several times to deflate the balloon, removing water each time.Finally the device was removed with the balloon partially inflated.No further medical intervention was required.
Additional Manufacturer Narrative
The reported event was confirmed.A 75 cc amber continuous irrigation lubricath foley was returned open with its original packaging, the balloon of the catheter appeared to be partially collapsed when returned.The catheter was filled with 80 ccs of water and then was passively deflated.It was found that a portion remained in the balloon remained inflated.Deflation issues would have failed the functional evaluation in the inspection procedure.A potential root cause could be due to "dull cutting tools", "operator error", or "insufficient drying".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: "warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst." 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.
Event or Problem Description
It was reported that the balloon could not be fully deflated.Per additional information from the ibc via email 13feb2020; the water was difficult to remove.The user tried several times to deflate the balloon, removing water each time.Finally the device was removed with the balloon partially inflated.No further medical intervention was required.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER CREEVY MODEL
• Common Device Name: 3 WAY IRRIGATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9759054
• Report Number: 1018233-2020-01381
• Device Sequence Number: 19560847
• Product Code: EZC
• UDI-Device Identifier: 00801741018817
• UDI-Public: (01)00801741018817
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K910195
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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: 02/28/2024
• Device Model Number: 01267522
• Device Catalogue Number: 01267522
• Device Lot Number: MCDP6416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1