MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC; PACK, HOT OR COLD, DISPOSABLE

Catalog Number MDS139007

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  malfunction  

Event Description

The dialysis nurse was preparing the hot pack, attempting to activate it and it burst open with contents coming into contact with the nurse's scrubs.No contact with the patient.

• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC; three lakes dr; northfield IL
• MDR Report Key: 9494703
• MDR Text Key: 171989905
• Report Number: 9494703
• Device Sequence Number: 1
• Product Code: IMD
• 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: 12/12/2019

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
• Device Catalogue Number: MDS139007
• Device Lot Number: VN19129-234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1