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

Model Number V11460-010

Device Problem Material Frayed (1262)

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

Event Date 09/10/2022

Event Type  malfunction  

Event Description

Customer reported, as i squeezed the infant heal warmer, the contents spewed out landing mostly on my arm, but some landed on the bed to the left of the infant.I had on a long sleeve scrub jacket that i immediately took off.I also removed the affected linens from the bed.

Manufacturer Narrative

Device history review was completed on the reported lot v2c242.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.Sample was not returned for evaluation due to which a root cause could not be determined.We will continue to monitor trends for this product.

• Brand Name: NOVAPLUS INFANT HEEL WARMER 4X4IN
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• 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: 15578423
• MDR Text Key: 303168371
• Report Number: 1423537-2022-00849
• 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,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• 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: V2H302-B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Female