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

Catalog Number 11450-040

Device Problem Split (2537)

Patient Problems Erythema (1840); Chemical Exposure (2570)

Event Date 10/02/2017

Event Type  malfunction  

Event Description

The heat pack split open upon activation and pushed the heated contents on the phlebotomist causing red areas.Hospital has had another event last week, but the instant pack was discarded.Rn states,"in activation of a instant hot pack cardinal health medium, the hot pack exploded on my clothes(chest area) and on my hands.Areas of reddened but did not burn." manufacturer response for cardinal health instant hot pack medium, hot pack instant medium (per site reporter): no response at this time.

• Brand Name: INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 1500 waukegan road; mcgaw park IL 60085
• MDR Report Key: 6934181
• MDR Text Key: 88865106
• Report Number: 6934181
• 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: 10/04/2017

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: Nurse
• Device Catalogue Number: 11450-040
• Device Lot Number: V7K274
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/04/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2017
• 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