MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC NOVAPLUS; PACK, HOT OR COLD, DISPOSABLE

Model Number V11460-010

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  malfunction  

Event Description

Registered nurse (rn) was in room with another rn, getting heat packs ready to be placed onto patient hands for peripheral iv (piv) insertion.The infant heel warmer then exploded as it was being activated, it exploded onto the nurse who was squeezing it.This rn was wearing gloves but the contents got on her neck, hands, arms, shirt and pants.The contents of the package did not get on the patient.Nurse is not injured and was able to change clothing but the heel warmer exploding could have resulted differently had it landed on a patient, etc.No treatment is needed for the rn at this time but wanted to report this as a supply concern and something that could have resulted differently.

• Brand Name: NOVAPLUS
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 18570422
• MDR Text Key: 333559746
• Report Number: 18570422
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V11460-010
• Device Catalogue Number: V11460-010
• Device Lot Number: VN23070A26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1