NOVAPLUS INFANT HEEL WARMER SQUEEZE

Description of Event or Problem

CUSTOMER REPORTED I ACTIVATED ANOTHER HEEL WARMER WITH THE SAME LOT NUMBER AS THE TWO THAT BURST EARLIER IN THE SHIFT. THIS HEEL WARMER WAS ACTIVE TOWARD THE GROUND WITHOUT A LOT OF FORCE AND IT BURST AND THE CONTENTS LANDED ON THE FLOOR. HAD I SQUEEZED HARDER THE WARMER WOULD HAD EXPLODED WITH A LOT MORE FORCE. NO INJURY.

Additional Manufacturer Narrative

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. 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. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS REPORTED ISSUE.

Additional Manufacturer Narrative

INITIAL REPORT WAS FILLED ON PRODUCT CODE 11460-010. BASED ON THE LOT REPORTED, THE CORRECT PRODUCT NUMBER IS V11460-010. 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.