MAUDE Adverse Event Report: CARDINAL HEALTH NOVAPLUS INFANT HEEL WARMER; HOT DISPOSABLE PACK

Catalog Number V11460-010

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2017

Event Type  malfunction  

Event Description

Heel warmer squeezed in preparation to use, and it exploded in staff member's face.

• Brand Name: NOVAPLUS INFANT HEEL WARMER
• Type of Device: HOT DISPOSABLE PACK
• Manufacturer (Section D): CARDINAL HEALTH; 808 w highway 24; moberly MO 65270
• MDR Report Key: 6968222
• MDR Text Key: 89946639
• Report Number: 6968222
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2017

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: No Information
• Device Catalogue Number: V11460-010
• Device Lot Number: V7L126
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1