MAUDE Adverse Event Report:; CATHETER, IRRIGATION

Device Problems Break (1069); Disconnection (1171)

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

Event Date 07/13/2020

Event Type  malfunction  

Event Description

Noted jp (jackson pratt drain) disconnected from tubing and stopper was broken.

• Type of Device: CATHETER, IRRIGATION
• MDR Report Key: 10657047
• MDR Text Key: 211539570
• Report Number: 10657047
• Device Sequence Number: 1
• Product Code: GBX
• 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: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA