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

Model Number 806516

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Irritation (1941); Rash (2033); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the patient said she experienced discomfort ¿all of a sudden¿; she said she will speak with her doctor about it.No medical intervention reported.Per additional information received from the patient's son on (b)(6) 2020, the patient had a rash and irritation.She received a prescription for a crème from her doctor.The name of the crème is unknown.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿materials of construction are not biocompatible¿ with a potential root cause of ¿immunological response on part of the patient¿.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: ¿visually inspect the product for any imperfections or surface deterioration prior to use.¿ 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.

Event Description

It was reported that the patient said she experienced discomfort ¿all of a sudden¿; she said she will speak with her doctor about it.No medical intervention reported.Per additional information received from the patients son on 3mar2020, the patient had a rash and irritation.She received a prescription for a crème from her doctor.The name of the crème is unknown.

• Brand Name: BARDIA® ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9780453
• MDR Text Key: 187845891
• Report Number: 1018233-2020-01480
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741039171
• UDI-Public: (01)00801741039171
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 806516
• Device Catalogue Number: 806516
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 03/03/2020
• Supplement Dates Manufacturer Received: 03/12/2020
• Supplement Dates FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other