MAUDE Adverse Event Report: CARDINAL HEALTH KWIK-KOLD COLD PK JR; COLD PACK

Model Number 102

Device Problem Burst Container or Vessel (1074)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/29/2016

Event Type  malfunction  

Manufacturer Narrative

A review was done on the device history record (dhr) for catalog number 102 lot v5l164.The lot was found to have been manufactured and released per predetermined specifications.No anomalies were found in the review of the records.Since a sample could not be obtained, the failure mode and root cause could not be determined.The plant's quality system mandates suitable in-process controls to measure seal integrity of representative samples.Fifty-five 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.If a sample is acquired at a later time, this complaint will be reopened and an additional investigation will be completed.No trend was identified for this issue.A review of this product catalog number 102 for the last eighteen months indicates that we have produced (b)(4) units with 2 complaints that may be similar to this issue.(b)(4).

Event Description

Based on the customers claim the kwik-kold pack burst when applied to the patient.This caused contact dermatitis, which the doctor was able to treat with unknown ointment.Per customer, no further treatment required.

• Brand Name: KWIK-KOLD COLD PK JR
• Type of Device: COLD PACK
• Manufacturer (Section D): CARDINAL HEALTH
• Manufacturer (Section G): CARDINAL HEALTH 200, LLC; 808 w highway 24; moberly MO
• Manufacturer Contact: michele donatich ; 1500 waukegan road; waukegan, IL 60085 ; 8478876412
• MDR Report Key: 5451973
• MDR Text Key: 39216730
• Report Number: 1423537-2016-00006
• 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: distributor,health profession
• Reporter Occupation: Medical Assistant
• Type of Report: Initial
• Report Date: 02/22/2016

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: 102
• Device Catalogue Number: 102
• Device Lot Number: V5L164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2016
• Initial Date FDA Received: 02/22/2016
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other