MAUDE Adverse Event Report: CARDINAL HEALTH MOBERLY COLD PACK, LARGE, 6X9IN; PACK, HOT OR COLD, DISPOSABLE

Model Number 11440-900

Device Problems Material Rupture (1546); Use of Device Problem (1670)

Patient Problem Eye Injury (1845)

Event Date 01/09/2017

Event Type  Injury  

Manufacturer Narrative

A device history record review was completed on the reported lot v6s299.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.Since no sample has been returned at this point, we cannot determine a failure mode or definitive root cause.The plant¿s quality system mandates suitable in-process controls to measure seal integrity of representative samples.One hundred and twenty-three samples from this lot were tested at predetermined locations to best gauge the seal integrity by pull test and functional leak testing.All samples pulled from this lot met the predetermined criteria before they were released.  a corrective action will not be initiated at this time since a sample is not available to confirm the issue and identify a root cause.

Event Description

Based on the information received from the customer, while activating a cardinal instant cold pack, the outer package ruptured.The contents of the cold pack splashed into the staff members face.She went to the emergency department and had her eyes irrigated for 20 minutes.

• Brand Name: COLD PACK, LARGE, 6X9IN
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer (Section G): CARDINAL HEALTH MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: michele donatich ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6287573
• MDR Text Key: 66115902
• Report Number: 1423537-2017-00070
• 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: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 11440-900
• Device Catalogue Number: 11440-900
• Device Lot Number: V6S299
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/09/2017
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 01/30/2017
• Date Device Manufactured: 09/01/2017
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other