MAUDE Adverse Event Report:; CATHETER, IRRIGATION

Device Problems Break (1069); Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 08/08/2020

Event Type  malfunction  

Event Description

Patient's jp drain (jackson pratt drain) was being pulled from the abdomen by the surgeon- he met slight resistance- as he continued to gently pull on the drain it broke in two pieces- the end of the tube had a jagged edge- the surgeon attempted to remove the retained tip of the jp drain by using a hemostat to grasp and remove it, but that effort was unsuccessful- the patient was taken to surgery where the retained tip of the jp drain was removed, without complications- unfortunately, when the jp drain was removed, the long bulb end was thrown away and no one retained the tip which was eventually removed.

• Type of Device: CATHETER, IRRIGATION
• MDR Report Key: 10655678
• MDR Text Key: 211539931
• Report Number: 10655678
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/11/2020

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2020
• 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 Outcome(s): Other
• Patient Age: 10585 DA