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

Model Number 165816

Device Problems Deflation Problem (1149); Decrease in Pressure (1490)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 Description

It was reported that the balloons were deflated.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause was not chosen due to a lack of information.The lot number was unknown; therefore, the device history record could not be reviewed.A labeling review was not completed due to a lack of information.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.

Event Description

It was reported that the balloons were deflated.

• Brand Name: BARDEX ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10385047
• MDR Text Key: 203294342
• Report Number: 1018233-2020-05091
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/15/2020

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
• Device Operator: Other
• Device Model Number: 165816
• Device Catalogue Number: 165816
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/18/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 11/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1