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

Model Number	0119L22
Health Effect - Clinical Code	No Code Available (3191)
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 foley catheter had a pinhole in the balloon, therefore the catheter balloon deflated after being inserted into the patient.
Additional Manufacturer Narrative
Received 1 used latex foley catheter.The reported event was confirmed as cause unknown.Visual inspection did not find anything to contribute to the reported event.Per functional testing, the balloon was inflated with air while submerged in water and found bubbles leaking from a pinhole in the balloon.Unable to determine if the pinhole was created before or after release.This 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 the foley catheter had a pinhole in the balloon, therefore the catheter balloon deflated after being inserted into the patient.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6973287
• Report Number: 1018233-2017-05427
• Device Sequence Number: 126644
• Product Code: EZC
• UDI-Device Identifier: 00801741019081
• UDI-Public: (01)00801741019081
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

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: 02/22/2022
• Device Model Number: 0119L22
• Device Catalogue Number: 0119L22
• Device Lot Number: CR7032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR