MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC NOVAPLUS; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number V11460-010

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

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

Event Date 07/10/2023

Event Type  malfunction  

Event Description

Phleb tech attempted to activate heel warmer to use on a patient with difficult venous access in late afternoon.Tech squeezed the pack to activate and the pack burst and leaked all over the patient's bed.Tech states that the patient was not injured and he cleaned up the contents off the bed.Tech was not affected by the leaked product.Note: there was a recall on this product june 16, 2023 but the lot number recalled was different (v2s506).This lot number may also be affected and should be reported to cardinal health.

• Brand Name: NOVAPLUS
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 17331936
• MDR Text Key: 319118130
• Report Number: 17331936
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2023

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: Other
• Device Model Number: V11460-010
• Device Catalogue Number: V11460-010
• Device Lot Number: V3A159F
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1