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

Catalog Number 30104

Device Problem Self-Activation or Keying (1557)

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

Event Date 01/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Upon receiving the shipment of hot packs, when the main box is opened many of the packs have already been activated and are no longer usable.

• Brand Name: CARDINAL HEALTH INSTANT HOT PACKS
• 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: 6328935
• MDR Text Key: 67356532
• Report Number: 6328935
• 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: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 30104
• Device Lot Number: V6P095
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: THE DEVICES WERE NOT USED ON A PATIENT AT THE TIME