NOVAPLUS INFANT HEEL WARMER SQUEEZE

Description of Event or Problem

DURING A VIRTUAL IN-SERVICE WITH THE TEAM AT (B)(6) CENTER, THE CUSTOMER IS REPORTING THAT THEY HAD INFANT HEEL WARMERS BURST WHILE ATTEMPTING TO ACTIVATE THEM. PACK CONTENTS LANDED ON NURSES RIGHT ARM, HAND AND FACE. SHE USED SOAP AND WATER TO CLEAN AND REMOVE CONTENTS AND NO OTHER MEDICATION WAS PROVIDED.

Additional Manufacturer Narrative

THIS COMPLAINT WAS FORWARDED TO THE MANUFACTURING FACILITY WHERE IT IS CURRENTLY STILL UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.

Additional Manufacturer Narrative

CARDINAL HEALTH HAS RECEIVED AN INCREASE IN BURST/LEAKING COMPLAINTS REGARDING THE NOVALPLUS INFANT HEEL WARMER WITH TAPE. CUSTOMER COMPLAINTS HAVE NOTED RUPTURING AND BURSTING OF THE DEVICE WHEN ACTIVATION IS ATTEMPTED, MAKING THE DEVICE UNUSABLE AND IN MANY CASES CAUSING THE CONTENTS INSIDE THE POUCH TO LEAK AND CONTACT CLINICIANS, PATIENTS, AND OTHER INDIVIDUALS OR SURFACES IN PROXIMITY. SAMPLES RETURNED TO CARDINAL HEALTH FROM CUSTOMERS HAVE BEEN EVIDENCED TO HAVE AN INCOMPLETE TOP SEAL, RESULTING IN THE MALFUNCTION. THERE HAVE BEEN NO REPORTABLE ADVERSE EVENTS/INJURIES ASSOCIATED WITH V11460-010, LOT V2S056. CARDINAL HEALTH HAS HALTED DISTRIBUTION OF THE NOVALPLUS INFANT HEEL WARMER W/TAPE FOR LOT NUMBER V2S056 AND INITIATED A VOLUNTARY RECALL ON JUNE 16, 2023.