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

Model Number	166818
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/26/2018
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 the user could not keep the balloon inflated during a period of two days.The balloon lost 30cc in that time.
Event or Problem Description
It was reported that the user could not keep the balloon inflated during a period of two days.The balloon lost 30cc in that time.
Additional Manufacturer Narrative
The reported event was confirmed as cause unknown.Received 1 used silicone catheter for evaluation.Per visual evaluation, no defects along the catheter were found.During functional evaluation, the balloon was inflated with 15cc of air, using a syringe, and it was deflated.The catheter balloon was then inflated with 10ml of a mix of tap water and blue methylene using a syringe and it was deflated due to two pin-holes in the balloon.The balloon active length was found to be within specifications.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: "recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 30cc balloon: use 35ml sterile water do not exceed recommended capacities.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use" 1149, 2199: "nl".

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Common Device Name: FOLEY SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7281890
• Report Number: 1018233-2018-00489
• Device Sequence Number: 16623770
• Product Code: GBM
• UDI-Device Identifier: 00801741029813
• UDI-Public: (01)00801741029813
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K760093
• 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): 03/28/2018

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: 11/30/2021
• Device Model Number: 166818
• Device Catalogue Number: 166818
• Device Lot Number: NGAY3219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1