MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC SILICONE FLAT DRAIN JACKSON PRATT 10MM; APPARATUS, SUCTION, SINGLE PATIENT USE

Device Problem Fracture (1260)

Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 07/18/2019

Event Type  Injury  

Event Description

During jp drain removal, tube fractured along round portion and half the tube was left inside the abdomen requiring laparoscopy removal of tube.

• Brand Name: SILICONE FLAT DRAIN JACKSON PRATT 10MM
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 8838098
• MDR Text Key: 152657559
• Report Number: MW5088434
• 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: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2019
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 43