NOVAPLUS

Description of Event or Problem

NOVAPLUS GAMMEX NON LATEX PI GLOVES OPENED FOR PROVIDER TO PUT ON PRIOR TO STERILE PROCEDURE. HE HAD DIFFICULTY ADVANCING ONE OF HIS FINGERS AND NOTICED THAT THE TOP PORTION OF THE GLOVE WAS CUT AND TWISTED AT THE TOP. GLOVES WERE NOT USED, AND A NEW PAIR WAS OPENED. REF V20685780, LOT MED01891. DEFECTIVE GLOVE GIVEN TO OUR OPERATIONS COORDINATOR, [REDACTED NAME]. MANUFACTURER RESPONSE FOR NOVAPLUS GAMMEX NON LATEX PI GLOVES, NOVAPLUS GAMMEX NON LATEX PI GLOVES (PER SITE REPORTER). ADDED TO TRACKER FOR TRENDING AND FDA REPORTING, REACHED OUT TO [REDACTED NAME] FOR PICTURES AND PRODUCTS. PICTURED EMBEDDED IN THIS LINE, [REDACTED NAME] FACILITATING RETRIEVAL AS OF [REDACTED DATE]. [REDACTED DATE]- EMAILED REP REQUESTING RMA AND MAILER LABEL. NEW REP IS [REDACTED NAME]. [REDACTED DATE]- SAMPLE SHIPPED FED-X. [REDACTED NAME] RMA CN-008653.