MAUDE Adverse Event Report: C. R. BARD, INC. UNKNOWN; CATHETER, RETENTION TYPE, BALLOON

Model Number UNKNOWN

Device Problems Detachment Of Device Component (1104); Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2018

Event Type  malfunction  

Event Description

Catheter was found in the bed with the balloon deflated.

• Brand Name: UNKNOWN
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7650393
• MDR Text Key: 112735012
• Report Number: 7650393
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/12/2018

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
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2018
• Date Report to Manufacturer: 06/29/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17885 DA