MCKESSON

Description of Event or Problem

CUSTOMER PROVIDED THE FOLLOWING DESCRIPTION: NEEDLE DOESN'T RETRACT WHEN BUTTON IS PUSHED.

Additional Manufacturer Narrative

A REVIEW OF THE BATCH MAUFACTURING RECORDS FOR THE REPORTED LOT WAS COMPLETED. THE REVIEW DID NOT IDENTIFY ANY DEVIATIONS DURING MANUFACTURING OR TESTING, AND ALL DOCUMENTED PARAMETERS WERE WITHIN THE APPROVED SPECIFICATION LIMITS. UNUSED SAMPLES FROM THE SAME LOT WERE RETURNED AND EVALUATED FOR VISUAL INSPECTION, AND FUNCTIONAL TESTING (NEEDLE SHARPNESS AND SAFETY MECHANISM). UPON EVALUATION OF THE UNUSED PRODUCT, NO NON-CONFORMANCES WERE OBSERVED. RETAINED SAMPLES FROM THE SAME LOT WERE ALSO INVESTIGATED. THE TESTS CONDUCTED WERE AS FOLLOWS: VISUAL INSPECTION: FUNCTIONAL TEST - GRIPPING OF CATHETER WITH NEEDLE. FUNCTIONAL TEST - PENETRATION TEST. FUNCTIONAL TEST - BEVEL HEAL DISTANCE TEST. FUNCTIONAL TEST - FITTING OF RETRACTABLE BUTTON WITH NEEDLE HUB. FUNCTIONAL TEST - SPRING ASSEMBLY. FUNCTIONAL TEST - SAFETY MECHANISM TEST. DURING TESTING OF THE RETAINED SAMPLES FOR THE REPORTED LOT, NO MANUFACTURING DEFECTS WERE OBSERVED. ALL RESULTS WERE FOUND TO BE WITHIN THE SPECIFIED LIMITS. NO ROOT CAUSE COULD BE IDENTIFIED. THE SUPPLIER GAVE THE FOLLOWING POTENTIAL ROOT CAUSES: MANUFACTURING DEFECT: MAY BE DUE TO IMPROPER INSPECTION OF THE PRODUCT. MAY BE DUE TO THE IV CANNULA TIP NOT BEING AT THE APPROPRIATE ANGLE OR FORMED WITHIN SPECIFICATION. THE SPRING MECHANISM MAY BE JAMMED, DAMAGED, OR NOT ASSEMBLED PROPERLY. USER ERROR: MAY BE DUE TO THE DEVICE NOT BEING HANDLED ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS. ATTEMPTING MULTIPLE INSERTIONS WITH THE SAME IV CANNULA REULTING IN A DULL NEEDLE. DROPPING OR PRESSING THE NEEDLE AGAINST HARD SURFACES. SAFETY MECHANISM MAY HAVE FAILED DUE TO MISHANDLING BY THE USER/HEALTH PROFESSIONAL.