MAUDE Adverse Event Report: MO016 MO-MOBERLY NOVAPLUS INFANT HEEL WARMER SQUEEZE; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number	V11460-010
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow up report will be filed once the results have been completed.
Event or Problem Description
During a virtual in-service with the team at la general med center, the customer is reporting that they had infant heel warmers burst while attempting to activate them.No one was injured as these were controlled tests.
Additional Manufacturer Narrative
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 (b)(6) 2023.

• Brand Name: NOVAPLUS INFANT HEEL WARMER SQUEEZE
• Common Device Name: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• 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: 17066329
• Report Number: 1423537-2023-00944
• Device Sequence Number: 6679722
• Product Code: MPO
• UDI-Device Identifier: 10192253061468
• UDI-Public: 10192253061468
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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
• Operator of Device: Health Professional
• Device Model Number: V11460-010
• Device Catalogue Number: V11460-010
• Device Lot Number: V28056 E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 71 KG