SYRINGE 10ML REG PR SALINE 10ML FILL

Additional Manufacturer Narrative

(B)(4) FOLLOW UP. THE LUER LOCK AREA OF THE SYRINGE WAS REPORTED TO BE CONTAMINATED WITH A DARK RED SUBSTANCE. BECAUSE THE PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE PERFORMED. ONE PHOTOGRAPH WAS PROVIDED AND REVIEWED BY THE QUALITY TEAM. THE IMAGE DEPICTS A PREFILLED SYRINGE WITHOUT FLOW WRAP PACKAGING, PLACED IN A PLASTIC BAG. DISCOLORATION IS VISIBLE ON THE SYRINGE BARREL LUER AND THE UPPER PORTION OF THE TIP CAP. NO OTHER DEFECTS OR IMPERFECTIONS ARE EVIDENT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 30654678, LOT 5262098. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING MANUFACTURE THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND THE PHOTOGRAPHIC EVIDENCE, THE CUSTOMER REPORTED CONDITION IS CONFIRMED. IN THE ABSENCE OF THE RETURNED PRODUCT, A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED BY CUSTOMER THAT THE NURSE NOTICED THE LEUR LOCK AREA OF THE SYRINGE WAS CONTAMINATED WITH A DARK RED SUBSTANCE. NO PATIENT HARM.

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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.