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	04/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.We received two samples for investigation that were not already activated.One sample was determined to have an incomplete top seal due to machine setup.The root cause was determined to be a burst pack due to an incomplete top seal.The machine was setup correctly and is designed with a mechanism which reduces the likelihood for this issue.Cardinal health will continue to monitor complaint trends for this reported issue.
Event or Problem Description
Customer reported nurse activated novaplus+ infant heel warmer as usual and the warmer opened and the content made contact with her tee shirt.Nurse stated she did not feel any splash onto her face but as a precaution i suggested she rinse her eyes with normal saline/water since some contents came in contact with her eye brow.No other demographics provided.
Additional Manufacturer Narrative
Initial report was filled on product code 11460-010.Based on the lot reported, the correct product number is v11460-010.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
• 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 drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 16841289
• Report Number: 1423537-2023-00917
• Device Sequence Number: 15175776
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2023

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 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: 04/18/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 04/30/2023
• Supplement Report FDA Received Date: 07/03/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female