SYRINGE 50ML CATHETER TIP BRAZIL

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT BLACK SPOTS ON THE SYRINGE TIP. NO PATIENT HARM.

Additional Manufacturer Narrative

(B)(4). FOLLOW UP IT WAS REPORTED THERE WERE BLACK SPOTS ON THE SYRINGE TIP. OUR QUALITY TEAM HAS COMPLETED A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER 303553 AND LOT NUMBER 4353316. THE REVIEW DID NOT IDENTIFY ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE CONDITION, AND ALL QUALITY TESTS WERE WITHIN SPECIFICATION. DUE TO THE UNAVAILABILITY OF A SAMPLE FOR RETURN, A COMPREHENSIVE SAMPLE INVESTIGATION COULD NOT BE CONDUCTED. CONSEQUENTLY, THE EXACT CAUSE OF THIS INCIDENT REMAINS UNDETERMINED. SHOULD YOU ENCOUNTER ANY FURTHER ISSUES WITH OUR PRODUCT, WE WOULD APPRECIATE THE OPPORTUNITY TO PERFORM A DETAILED ANALYSIS. AT THIS TIME, NO FURTHER ACTION IS DEEMED NECESSARY.

Additional Manufacturer Narrative

PR (B)(4) FOLLOW UP: A COMPLAINT WAS RECEIVED ALLEGING THE PRESENCE OF BLACK SPOTS ON THE SYRINGE TIP. BECAUSE A PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE HANDS ON EVALUATION COULD NOT BE PERFORMED. TO SUPPORT THE INVESTIGATION, THREE PHOTOGRAPHS WERE PROVIDED AND REVIEWED BY THE QUALITY TEAM. THE IMAGES DEPICT A SYRINGE WITH A SINGLE DARK COLORED SPECK LOCATED AT THE SYRINGE CAP THAT APPEARS TO BE EMBEDDED. NO ADDITIONAL DEFECTS OR ANOMALIES WERE OBSERVED IN THE PHOTOGRAPHS. AN EMBEDDED SPECK OF THIS NATURE IS CONSISTENT WITH DEGRADED RESIN INTRODUCED DURING THE INJECTION MOLDING PROCESS, WHICH CAN OCCUR AT START UP OR INTERMITTENTLY AND MAY DETACH AND BECOME INCORPORATED INTO MOLDED COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 303553, LOT 4353316. THIS REVIEW DID NOT IDENTIFY ANY IN PROCESS OR FINAL INSPECTION NONCONFORMANCES THAT WOULD BE EXPECTED TO CONTRIBUTE TO THE REPORTED CONDITION, AND THERE WERE NO RELATED QUALITY NOTIFICATIONS ASSOCIATED WITH THIS LOT. ALL MANUFACTURING AND INSPECTION ACTIVITIES WERE PERFORMED IN ACCORDANCE WITH APPLICABLE SPECIFICATIONS. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND THE PHOTOGRAPHIC EVALUATION, THE CUSTOMER REPORTED CONDITION IS CONFIRMED.