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

Model Number	0196L22
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/25/2017
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 information provided by bard 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 bard.
Event or Problem Description
It was reported that when the catheter was removed, the balloon was noted to be in fragments.It was later reported fragments were left in the patient, however the patient's family chose not to have them removed.The catheter was placed by a physician during a cystogram on (b)(6) 2017.
Additional Manufacturer Narrative
Received 1 used foley catheter with the patient's sticker and drainage bag.The reported event was confirmed as cause unknown.Per the visual inspection, the sample was examined and found that the balloon burst with no pieces missing.Per the dimensional inspection, it was found that the balloon measured 0.028" thick.The root cause was unable to be determined.It may occur during the dipping operation of manufacturing.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." (b)(4).
Event or Problem Description
It was reported that when the catheter was removed, the balloon was noted to be in fragments.It was later reported fragments were left in the patient, however the patient's family chose not to have them removed.The catheter was placed by a physician during a cystogram on (b)(6) 2017.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUNCILL MODEL
• Common Device Name: CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6709449
• Report Number: 1018233-2017-03708
• Device Sequence Number: 772204
• Product Code: EZC
• UDI-Device Identifier: 00801741017957
• UDI-Public: (01)00801741017957
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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: 02/16/2021
• Device Model Number: 0196L22
• Device Catalogue Number: 0196L22
• Device Lot Number: CD6158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR