SYRINGE CATHETER TIP 50ML

Additional Manufacturer Narrative

PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION. A SYRINGE WAS REPORTED TO CONTAIN INTERNAL RESIDUE. TO SUPPORT THE INVESTIGATION, THE QUALITY TEAM RECEIVED ONE SAMPLE IN A SEALED BLISTER PACKAGE AND THREE PHOTOGRAPHS FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND A STAIN CONSISTENT WITH EQUIPMENT LUBRICANT WAS OBSERVED ON THE BOTTOM WEB OF THE PACKAGING BLISTER. THE THREE PHOTOGRAPHS PROVIDED DEPICT THE SAMPLE AS RECEIVED. NO ADDITIONAL DEFECTS OR IMPERFECTIONS WERE NOTED. THIS CONDITION COULD OCCUR IF EQUIPMENT LUBRICANT RESIDUES WERE NOT FULLY REMOVED FOLLOWING EQUIPMENT MAINTENANCE OR REPAIR. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 309620, LOT 5212902. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DETECTED DURING PRODUCTION THAT WOULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, AND NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS MET APPLICABLE SPECIFICATION REQUIREMENTS. THE SAMPLE WILL BE SHARED WITH ASSOCIATES FOR AWARENESS. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND THE RETURNED SAMPLE EVALUATION, THE CUSTOMER REPORTED CONDITION IS CONFIRMED.

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 BY THE CUSTOMER THAT THEY RECEIVED A SYRINGE WITH SOME RESIDUE ON THE INSIDE.