INFANT HEEL WARMER SQUEEZE 4X4IN

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.

Additional Manufacturer Narrative

WE RECEIVED TWO SAMPLES FOR INVESTIGATION THAT WERE NOT ALREADY ACTIVATED. ONE SAMPLE WAS DETERMINED TO HAVE AN INCOMPLETE TOP SEAL DUE TO MACHINE SETUP. THE ROOT CAUSE WAS DETERMINED TO BE A BURST PACK DUE TO AN INCOMPLETE TOP SEAL. THE MACHINE WAS SETUP CORRECTLY AND IS DESIGNED WITH A MECHANISM WHICH REDUCES THE LIKELIHOOD FOR THIS ISSUE. DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT V2S056. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS.

Description of Event or Problem

CARDINAL HEALTH INFANT HEEL WARMER, BURST WHILE NURSE WAS ACTIVATING. SHE DID NOT SEEK ANY MEDICAL CARE AS SHE STATES THE CONTENTS OF THE HEEL WARMER LANDED MAINLY ON HER CHEST, DOWN HER UNIFORM AND ON HER PANTS. SHE WAS WEARING GLOVES AND CONTENTS DID NOT MAKE CONTACT WITH SKIN.