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

Model Number V11460-010

Device Problem Burst Container or Vessel (1074)

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

Event Date 03/30/2023

Event Type  malfunction  

Manufacturer Narrative

We received nineteen samples for evaluation.Upon receipt, one out of the nineteen were already activated.That one each that was activated was inspected and failure mode burst/leak was unable to be confirmed via evaluation of the returned device; the product was not leaking.The remaining eighteen samples were activated and inspected for failure.Five samples leaked from the top seal.The root cause for the nonconforming product was determined to be an incomplete top seal.The machine was setup correctly and is designed with a mechanism which reduces the likelihood for this issue.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 will continue to monitor complaint trends for this reported issue of burst and work to identify improvement activities to minimize reoccurrence.

Event Description

Customer has reported that the seal at the top of the warmer would open when pressure was applied.While a caregiver attempted to activate the infant heel warmer it burst and landed in her eye.The eye wash station was used to rinse out her eye and she was seen by the hospital ophthalmologist.The caregiver is doing fine.

• Brand Name: NOVAPLUS INFANT HEEL WARMER SQUEEZE
• Type of Device: 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 bichwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 16791927
• MDR Text Key: 313827810
• Report Number: 1423537-2023-00912
• Device Sequence Number: 1
• Product Code: MPO
• UDI-Device Identifier: 10192253061468
• UDI-Public: 10192253061468
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 04/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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
• Patient Sex: Female