MAUDE Adverse Event Report: CARDINAL HEALTH CARDINAL HEALTH JACKSON PRATT 10F DRAIN; JACKSON PRATT 10F DRAIN

Catalog Number SU130-0321

Device Problem Torn Material (3024)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 12/17/2017

Event Type  Injury  

Event Description

Pt underwent spinal surgery with instrumentation.On the fourth post operative day, during removal of a 10f jackson pratt drain, the drain tubing ripped leaving a piece of the tubing retained in the thoracic area of the pt's body.

• Brand Name: CARDINAL HEALTH JACKSON PRATT 10F DRAIN
• Type of Device: JACKSON PRATT 10F DRAIN
• Manufacturer (Section D): CARDINAL HEALTH; 7000 cardinal place; dublin OH 43017
• MDR Report Key: 7203010
• MDR Text Key: 97803776
• Report Number: MW5074663
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/11/2018

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?: Yes
• Device Operator: No Information
• Device Catalogue Number: SU130-0321
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 54