MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® FOLEY CATHETER SILICONE COATED; BARDIA 2 WAY CATHETER

Model Number	123522A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2017
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, after an unusual sound, the foley fell out and the balloon rupture was found.The patient stated that the foley was implemented on (b)(6).It was confirmed that no pieces were left inside the patient.
Additional Manufacturer Narrative
The reported event was confirmed.Received only a photo of the catheter for evaluation.Per inspection of the photo received, it was confirmed that there was a sac burst along the inflation lumen.The root cause was unable to be determined based on the photo.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "do not use ointments or lubricants having a petrolatum base.They will damage latex and may burst balloon." (b)(4).
Event or Problem Description
It was reported that, after an unusual sound, the foley fell out and the balloon rupture was found.The patient stated that the foley was implemented on (b)(6).It was confirmed that no pieces were left inside the patient.

• Brand Name: BARDIA® FOLEY CATHETER SILICONE COATED
• Common Device Name: BARDIA 2 WAY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; lot 57c; covington GA 30014
• MDR Report Key: 6709427
• Report Number: 1018233-2017-03707
• Device Sequence Number: 18965770
• Product Code: EZC
• UDI-Device Identifier: 00801741095122
• UDI-Public: (01)00801741095122
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2018

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 Model Number: 123522A
• Device Catalogue Number: 123522A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 02/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1