MAUDE Adverse Event Report: MO016 MO-MOBERLY NOVAPLUS INFANT HEEL WARMER SQUEEZE; 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 06/22/2023

Event Type  malfunction  

Event Description

It has been reported that a novaplus heel warmer burst on a staff member at their hospital.There was no injury or adverse effect, and no medication was provided to staff member due to the heel warmer bursting.

Manufacturer Narrative

The returned sample was investigated, and we are unable to determine the root cause.Device history record review was completed on the reported lot v2s056.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.Cardinal health has received an increase in burst/leaking complaints regarding the novalplus infant heel warmer with tape.Customer complaints have noted rupturing and bursting of the device when activation is attempted, making the device unusable and in many cases causing the contents inside the pouch to leak and contact clinicians, patients, and other individuals or surfaces in proximity.Samples returned to cardinal health from customers have been evidenced to have an incomplete top seal, resulting in the malfunction.There have been no reportable adverse events/injuries associated with v11460-010, lot v2s056.Cardinal health has halted distribution of the novalplus infant heel warmer w/tape for lot number v2s056 and initiated a voluntary recall on june 16, 2023.

• Brand Name: NOVAPLUS INFANT HEEL WARMER SQUEEZE
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• 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: 17346730
• MDR Text Key: 320233079
• Report Number: 1423537-2023-00962
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380057588
• UDI-Public: 10885380057588
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/18/2023

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: V2S056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1