SYRINGE 10ML SALINE POSIFLUSH SAFESCRUB

Additional Manufacturer Narrative

INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

Description of Event or Problem

EVENT DETAILS: MATERIAL #303191. LOT #4297081. IT WAS REPORTED BY CUSTOMER THAT FOUND BLACK/BROWN CONTAMINATE IN/ON TIP OF SYRINGE AFTER REMOVING CAP.

Additional Manufacturer Narrative

(B)(6). FOLLOW UP. A REPORT WAS RECEIVED INDICATING THE PRESENCE OF A BROWN CONTAMINANT AT THE TIP OF A SYRINGE. AS THE PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE CONDUCTED. TO SUPPORT THE INVESTIGATION, THREE PHOTOGRAPHS WERE PROVIDED AND REVIEWED BY THE QUALITY TEAM. TWO OF THE IMAGES DEPICT AN EMPTY SYRINGE REMOVED FROM ITS FLOW WRAP PACKAGING, LACKING A TIP CAP, WITH A DARK-COLORED SPECK VISIBLE IN THE LUER TIP OF THE SYRINGE BARREL. THE THIRD IMAGE DISPLAYS THE SYRINGE BARREL LABEL. NO ADDITIONAL DEFECTS OR IRREGULARITIES WERE OBSERVED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR MATERIAL NUMBER 303191, LOT 4297081. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD BE LINKED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR INCIDENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE AVAILABLE INFORMATION AND PHOTOGRAPHIC EVIDENCE, THE CUSTOMER-REPORTED CONDITION IS CONFIRMED. HOWEVER, IN THE ABSENCE OF THE PHYSICAL SAMPLE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.