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

Model Number	11440-012B
Medical Device Problem Codes	Break (1069); Burst Container or Vessel (1074)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Employee was attempting to activate the cardinal health non-sweat instant cold pack when the cold pack burst at the seam and exploded in the employee's face and eyes exposing them to the chemical.Employee rushed to the eye wash station to rinse their face and eyes, using soap on her skin as instructed on the package.This non-sweat cold pack was a large (6" x 9"), ref 11440-012b and the package was fabric in nature.The active ingredients (ammonium nitrate pellets and a pouch containing water) are the same as the large (6" x 9"), cardinal health instant cold pack, ref 11440-900 (package is plastic, see second picture below).The employee was using item as recommended by manufacturer and no user misuse was identified by the manager and safety specialist.The employees informed safety that the non-sweat cold packs were difficulty to activate and reported, that it happened on more than one occasion.This instance resulted in an eligible employee getting injury.This injury was not the result of lack of training or end user error.Employee activated a large (6" x 9") non-sweat instant cold pack by squeezing the sides together as instructed on the package, which will break the inner pouch containing water, to dissolve the ammonium nitrate upon shaking the package.Due to the inconsistence with the thickness of the side seams the outer pouch/fabric package, broke at the thinner seam allowing the aqueous ammonium nitrate to escape and splash on the face and in the eyes of the employee.The quality control for manufacturing these non- sweat cold packs is poor.There are two different packaging types of ice packs used in our facility; one has fabric (non-sweat instant cold pack), and the other is smooth plastic, branded as instant cold pack see second image above), manufactured by cardinal health.Our facility safety department activated five of the fabric packaging ice pack and two of them broke at the side seam, allowing the aqueous ammonium nitrate to escape.Safety discovered that the thickness of the seams was not the same consistently.On average the seams are approximately ½ inch wide on both sides.However, the two that broke, had seams that were approximately 1/16 - 1/8 of an inch on the side that broke and the other side had the standard ½ inch thickness.We found this inconsistence with multiple of the fabric packaging on the unit, that is the cardinal health non-sweat instant cold packs.This inconsistency was not observed with the instant cold packs, that is, the plastic packaging cold packs.Fda safety report id #(b)(4).

• Brand Name: NON-SWEAT INSTANT COLD PACK
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 15708037
• Report Number: MW5112987
• Device Sequence Number: 10376174
• Product Code: IMD
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/28/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11440-012B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown