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

Catalog Number 11440-900

Device Problem Leak/Splash (1354)

Patient Problem Burning Sensation (2146)

Event Date 07/20/2022

Event Type  malfunction  

Event Description

No patient affected.Staff were squeezing the cold pack to activate it for the patient when the liquid inside the bag leaked on the employees hand and the chemicals started to burn.No injury to the employee.Hands were washed.Lot number was pulled.Cardinal health cold packs with micro holes.Lot#v2d107, cat#11440-900.Fda safety report id# (b)(4).

• Brand Name: COLD PACKS
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINALHEALTH 200, LLC.
• MDR Report Key: 15282719
• MDR Text Key: 298595664
• Report Number: MW5111667
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11440-900
• Device Lot Number: V2D107
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 91 KG