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

Model Number U9E352

Device Problems Burst Container or Vessel (1074); Device Markings/Labelling Problem (2911)

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

Event Date 07/16/2019

Event Type  malfunction  

Event Description

Cardinal packets labeled as "hot packs".Several were popping apart when correctly activated.Additionally, it was revealed that these were actually cold packs, that were labeled as hot packs.The manufacturer will be receiving the entire lot returned and replacing.We have checked other lots and found no issues.

• Brand Name: HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 9117677
• MDR Text Key: 160030491
• Report Number: 9117677
• 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: 07/18/2019

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 Model Number: U9E352
• Device Catalogue Number: 0000
• Device Lot Number: V9E352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2019
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16425 DA
• Patient Weight: 50