MAUDE Adverse Event Report: CARDINAL HEALTH COLD PAK SM/LONG 4.5X9; INSTANT COLD PACK

Catalog Number 11440-512

Device Problems Burst Container or Vessel (1074); Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 10/06/2015

Event Type  malfunction  

Manufacturer Narrative

The device history record was reviewed, the lot was found to have been manufactured and released per predetermined specifications.No anomalies were found in the review of the records.No trend was identified for this issue.The sample was received.After evaluation it was determined the top seal may not have received adequate pressure when sealing this pack.The plant¿s quality system mandates suitable in-process controls to measure seal integrity of representative samples.(b)(4) samples were pulled during production of this lot and 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 it was released.(b)(4).

Event Description

(b)(6) sustained a splash in both eyes when the cold pak burst.She was sent to industrial clinic where they flushed both of her eyes with a saline solution, then they placed yellow dye in both eyes and scanned them with a fluorescent light to see if there was any leftover residue.She was sent home and told to purchase 'refresh tears' and instructed to use as needed.

• Brand Name: COLD PAK SM/LONG 4.5X9
• Type of Device: INSTANT COLD PACK
• Manufacturer (Section D): CARDINAL HEALTH; 808 highway 24 w; moberly MO 65270
• Manufacturer (Section G): CARIDNAL HEALTH 200, LLC; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: michele donatich ; 1500 waukegan road; waukegan, IL 60085 ; 8478876412
• MDR Report Key: 5204035
• MDR Text Key: 30727566
• Report Number: 1423537-2015-00073
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2015

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: Nurse
• Device Catalogue Number: 11440-512
• Device Lot Number: V5K057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50
• Patient Weight: 68