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

Model Number JP-2190

Device Problems Break (1069); Nonstandard Device (1420); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/21/2019

Event Type  Injury  

Event Description

Note: this drain has been recalled.Because the lot number is unknown, we do not know if this was an affected lot number or not.A 19fr drain was placed inter-operatively.When the drain was removed by the rn, a portion of the drain broke off and was left inside the patient.

• Brand Name: JACKSON-PRATT
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 9488694
• MDR Text Key: 171824300
• Report Number: 9488694
• 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: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JP-2190
• Device Catalogue Number: JP-2190
• 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: 10/14/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention