FDA Adverse Event
Malfunction
Summary report: N
CARDINAL HEALTH
MDR report key: 20332428
·
Received September 30, 2024
Report
- Report Number
- 20332428
- Event Type
- Malfunction
- Date Received
- September 30, 2024
- Date of Event
- June 20, 2024
- Report Date
- June 25, 2024
- Manufacturer
- CARDINAL HEALTH 200, LLC
- Product Code
- MPO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MD
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
[DATE REDACTED]: INFANT HEEL WARMER EXPLODED WHEN ACTIVATED, AND CONTENTS SPRAYED OVER THE NEONATE INTENSIVE CARE UNIT (NICU) NURSE. EMPLOYEE HEALTH AND NURSING LEADERSHIP NOTIFIED. [DATE REDACTED]: POSTPARTUM UNIT NURSE ATTEMPTED TO ACTIVATE INFANT HEEL WARMER (INSTANT SQUEEZE ACTIVATION). DURING ACTIVATION PROCESS, THE TOP PORTION OF THE PRODUCT SPLIT OPEN AND CONTENT SPLASHED IN THE EMPLOYEE¿S FACE AND EYES. NO PHYSICAL INJURIES REPORTED OR IDENTIFIED. THE EMPLOYEE¿S CONTACT LENSES WERE DAMAGED. EMPLOYEE HEALTH AND NURSING LEADERSHIP NOTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2585116 | CARDINAL HEALTH | INFANT HEEL WARMER (CHEMICAL HEAT PACK) | MPO | CARDINAL HEALTH 200, LLC | 11460-010T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |