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

Model Number	710018S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
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 patient needed a bigger balloon (30 cc) so they tried to overfill 5 cc and it burst.The foley was replaced.
Event or Problem Description
It was reported that the patient needed a bigger balloon (30 cc) so they tried to overfill 5 cc and it burst.The foley was replaced.
Additional Manufacturer Narrative
The reported event was confirmed.No sample was returned for evaluation.The user failed to follow the instructions provided in the labeling.These provisions were found adequate to prevent the reported event.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "10cc syringe (contains 9cc sterile water) to inflate foley catheter only" and give the instruction "to inflate catheter balloon, insert syringe tip into valve (do not overpenetrate) and depress plunger" with the additional instruction "should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." 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.

• Brand Name: BARDEX® SILICONE ELASTOMER-COATED FOLEY CATHETER KIT
• Common Device Name: SILICONE FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8708173
• Report Number: 1018233-2019-03171
• Device Sequence Number: 1845124
• Product Code: EZC
• UDI-Device Identifier: 00801741046551
• UDI-Public: (01)00801741046551
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

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: Lay User/Patient
• Device Model Number: 710018S
• Device Catalogue Number: 710018S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1