MAUDE Adverse Event Report: CARDINAL HEALTH #10 FLAT JACKSON PRATT DRAIN; CATHETER IRRIGATION

Model Number #10 FLAT

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/12/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, during removal of a #10 flat jackson pratt drain from the lumbar spine, the jackson pratt drain tubing broke leaving the distalmost aspect of the drain in the wound.This requires a trip to the operating room on (b)(6) 2018 for the jackson pratt drain removal which extended the hospital stay by several days.

• Brand Name: #10 FLAT JACKSON PRATT DRAIN
• Type of Device: CATHETER IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 7673501
• MDR Text Key: 113675779
• Report Number: MW5078302
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: #10 FLAT
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 113