MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC INSTANT HOT PACK; PACK, HOT OR COLD, DISPOSABLE

Catalog Number 11440-012

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2017

Event Type  malfunction  

Event Description

Stocked instant cold pack found to be empty of contents but the pack was sealed with manufacturing.Manufacturer response for instant cold pack, instant cold pack (per site reporter): emailed local cardinal rep, but have not received a response yet.

• Brand Name: INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 808 w. highway 24; moberly MO 65270
• MDR Report Key: 6345889
• MDR Text Key: 67860317
• Report Number: 6345889
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 11440-012
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO, NOT USED ON PATIENT.; NOT APPLICABLE.