MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC NOVAPLUS INFANT HEEL WARMER 4X4IN; PACK, HOT OR COLD, DISPOSABLE

Model Number V11460-010

Device Problem Burst Container or Vessel (1074)

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

Event Date 01/01/1980

Event Type  malfunction  

Event Description

Customer report that when activating the infant heel warmer as instructed, it burst, and contents went across the room hitting staff member.The staff member was wearing gloves, therefore no skin exposure or adverse event to staff or patient.No demographic or other information provided.

Manufacturer Narrative

Device history review was completed on the reported lot number, v2a051.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.We received one sample for investigation on 5/25/2022.The sample was not activated.The returned sample was visually inspected, and no issues were identified.The product was then activated, and no issues were identified.Therefore, the failure could not be confirmed through evaluation of this returned device.Cardinal health will continue to monitor complaint trends.

• Brand Name: NOVAPLUS INFANT HEEL WARMER 4X4IN
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood dr.; waukegan IL 60085
• Manufacturer (Section G): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 14681622
• MDR Text Key: 301274846
• Report Number: 1423537-2022-00789
• 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: 06/13/2022

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: V2A051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1