MONOJECT

Description of Event or Problem

CUSTOMER REPORTED THAT THE NURSES HAD AN INCIDENT OF A MONOJECT NEEDLE BREAKING OFF INTO A PATIENT'S ARM.THE NURSING SUPERVISOR STATED THAT THE NEEDLE BROKE OFF INTO PATIENT'S DELTOID WHILE ADMINISTERING ROCEPHIN MEDICATION ON (b)(6) 2026. THE PATIENT WAS SENT TO THE ER FOR MEDICAL REVIEW ON (b)(6) 2026 AND WAS LATER SCHEDULED FOR SURGERY IN THE OR ON (b)(6) 2026 TO HAVE THE NEEDLE SURGICALLY REMOVED. THE PATIENT BEEN DISCHARGED FROM THE HOSPITAL.

Additional Manufacturer Narrative

THE MANUFACTURER CONDUCTED AN INVESTIGATION THAT INCLUDED EVALUATION OF THE RETURNED SAMPLE, REVIEW OF THE DEVICE HISTORY RECORDS, COMPLAINT TREND ANALYSIS, AND TESTING OF RETAINED SAMPLES FROM THE COMPLAINT LOT. NO MANUFACTURING ABNORMALITIES WERE IDENTIFIED DURING THE INVESTIGATION. TESTING OF SAMPLES FROM THE COMPLAINT LOT DEMONSTRATED COMPLIANCE WITH THE APPLICABLE MECHANICAL PERFORMANCE REQUIREMENTS OF ISO 9626:2016, AND THE REPORTED FAILURE MODE COULD NOT BE REPRODUCED. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY EVIDENCE OF A MANUFACTURING OR MATERIAL DEFICIENCY ASSOCIATED WITH THE COMPLAINT LOT. CANNULA DAMAGE OR FRACTURE MAY OCCUR IF EXCESSIVE FORCE OR BENDING IS APPLIED DURING USE; HOWEVER, THIS CONDITION COULD NOT BE CONFIRMED FOR THE REPORTED EVENT. NO ADVERSE TREND ASSOCIATED WITH THIS FAILURE MODE HAS BEEN IDENTIFIED. BASED ON THE INVESTIGATION RESULTS, NO FURTHER CORRECTIVE OR PREVENTIVE ACTIONS ARE CONSIDERED NECESSARY AT THIS TIME. THE COMPLAINT WILL CONTINUE TO BE MONITORED THROUGH THE MANUFACTURER'S POST-MARKET SURVEILLANCE PROCESS.