MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC JACKSON-PRATT; ACCESSORIES, CATHETER

Model Number JP-2214

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/16/2022

Event Type  malfunction  

Event Description

Jackson-pratt® drain could not be easily removed by staff.A trauma clinical staff came in to remove it, and the drain broke off.Patient needed to be sent back to operating room to get retained drain removed.

• Brand Name: JACKSON-PRATT
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 14619296
• MDR Text Key: 293474093
• Report Number: 14619296
• Device Sequence Number: 1
• Product Code: KGZ
• 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: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: JP-2214
• Device Catalogue Number: JP-2214
• 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: 04/27/2022
• Date Report to Manufacturer: 06/07/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8395 DA