NOVAPLUS INFANT HEEL WARMER SQUEEZE

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.

Description of Event or Problem

CUSTOMER REPORTED NURSE ACTIVATED A HEEL WARMER AND IT BURST IN HER HAND AND THE CONTENTS CAME IN CONTACT WITH HER UNIFORM, FACE, AND EYES. SHE FLUSHED HER EYES WITH WATER AS WE DON¿T HAVE AN ¿EYE WASH STATION¿ IN THE NURSERY OR ON THE THIRD FLOOR. THE NURSE WAS TAKEN TO THE EMERGENCY ROOM AND TREATED. HER EYES WERE REDDENED AND SWOLLEN. THERE WAS IRRIGATION TO THE EYE(S) NOTED FROM A PICTURE, HOWEVER THE EXTENT OF TREATMENT IS NOT KNOWN SINCE IT WAS DONE IN ED. SHE WAS TAKEN OFF OF WORK AND HAS AN OPHTHALMOLOGIST APPOINTMENT FOR FOLLOW UP CARE.

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.