MAUDE Adverse Event Report: CARDINAL HEALTH SINGLE-USE INSUL HOT PK 6X9; HOT PACK

Model Number 30104

Device Problem Burst Container or Vessel (1074)

Patient Problems Pain (1994); Blurred Vision (2137); Burning Sensation (2146)

Event Date 04/08/2016

Event Type  Injury  

Manufacturer Narrative

At the time of this investigation the lot number and sample were not provided.Without the lot number we could not review the device history record (dhr).Without the issue sample we could not determine the failure mode and root cause.The plant¿s quality system mandates suitable in-process controls to measure seal integrity of representative samples.(b)(4) samples were randomly 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 they were released.If a sample is acquired at a later time, this complaint will be reopened and an additional investigation will be completed.It should be noted that there are no chemicals present that would produce gases or other ¿explosive¿ elements when the pack is activated.Also, the chemicals used in the product are sodium thiosulfate (food grade, non-toxic), dextrose and water.The maximum temperature that the product can reach is 114.1 degrees fahrenheit.(b)(4).

Event Description

Based on the customers report the rn was going to start an iv and went to place a hot pack on the right arm, while activating the hot pack by squeezing it the contents exploded out the top and went all over the patient.Per the report some of the contents of the hot pack went into the patient's eye.The patient complained of right eye burning and blurring.The rn flushed the patient's eye with an eye washer for 2 minutes, however the patient continued to complain of pain.The rn took the patient to the er where his right eye could be looked at by a doctor.Eye was irrigated as per recommendation from poison control.

• Brand Name: SINGLE-USE INSUL HOT PK 6X9
• Type of Device: HOT PACK
• Manufacturer (Section D): CARDINAL HEALTH; 808 highway 24 w; moberly MO
• Manufacturer (Section G): CARDINAL HEALTH; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: michele donatich ; 1500 waukegan road; waukegan, IL 60085 ; 8478876412
• MDR Report Key: 5633481
• MDR Text Key: 44463042
• Report Number: 1423537-2016-00022
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/05/2016

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: 30104
• Device Catalogue Number: 30104
• Device Lot Number: NO LOT GIVEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2016
• Initial Date FDA Received: 05/05/2016
• 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: 52 YR