MAUDE Adverse Event Report: C. R. BARD, INC. BARD® URODYNAMIC CATHETER, DOUBLE LUMEN; DEVICE, CYSTOMETRIC, HYDRAULIC

Lot Number 19CBH027

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 05/22/2019

Event Type  malfunction  

Event Description

Picc was placed and had a kink in the line.

• Brand Name: BARD® URODYNAMIC CATHETER, DOUBLE LUMEN
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 8980135
• MDR Text Key: 157098351
• Report Number: 8980135
• Device Sequence Number: 1
• Product Code: FEN
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 19CBH027
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2019
• Type of Device Usage: N
• Patient Sequence Number: 1