EMBOSPHERE

Additional Manufacturer Narrative

ONE UNIT WAS RETURNED BY THE CUSTOMER AND RECEIVED ON 05APR2024. THE CUSTOMER PROVIDED ONE PHOTOGRAPH OF THE SUSPECT DEVICE THAT HAD LEAKED RESULTING IN THE EMBOSPHERE BEING DRIED. THE PHOTOGRAPH DISPLAYED A PARTIALLY FILLED SYRINGE WITH A CRACK ON THE LUER, CONFIRMING THE REPORTED ISSUE. A DHR REVIEW WAS PERFORMED AND YIELDED NO EXCEPTION DOCUMENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED FAILURE. NO ANOMALY WAS RECORDED DURING THE MONITORING OF UNSCREWING PROCESS FOR THIS BATCH. DURING PACKAGING INSPECTION STEP, NO UNIT WITH CAP LUER LOCK DISPLAYED CRACKS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

Additional Manufacturer Narrative

THIS EVENT WAS IDENTIFIED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. UPON REVIEW, THE MANUFACTURER DETERMINED THE EVENT MEETS FDA CRITERIA FOR REPORTING. THE REPORT IS BEING SUBMITTED TO ENSURE ACCURACY AND COMPLETENESS OF MDR FILES. THIS SUBMISSION DOES NOT REFLECT A CHANGE IN DEVICE PERFORMANCE OR PATIENT RISK. THE AWARENESS DATE CORRESPONDS TO WHEN THE MANUFACTURER BECAME AWARE OF THE EVENT DETAILS. ALL INFORMATION REASONABLY KNOWN TO THE MANUFACTURER AT THIS TIME HAS BEEN INCLUDED. THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT WAS CONFIRMED; THERE WAS A CRACK ON THE LUER. THE ROOT CAUSE WAS DETERMINED TO POTENTIALLY BE HUMAN ERROR DURING THE SCREWING PROCESS. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.

Description of Event or Problem

THE CUSTOMER STATED THAT AFTER OPENING THE PACKAGE, THEY FOUND THE DEVICE HAD LEAKED LIQUID RESULTING IN THE EMBOSPHERE BEING DRIED.