SYRINGE 5ML HEPARIN 10 UNIT

Additional Manufacturer Narrative

PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION. A CUSTOMER REPORTED THAT THE HEPARIN SOLUTION IN THE SYRINGE HAD DISAPPEARED. TO SUPPORT THE INVESTIGATION, ONE SAMPLE¿RECEIVED WITHOUT ITS PACKAGING FLOW WRAP¿AND TWO PHOTOGRAPHS WERE PROVIDED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION WAS CONDUCTED. THE SYRINGE¿S PLUNGER ROD AND RUBBER STOPPER WERE POSITIONED AT THE 4ML MARK ON THE GRADUATION SCALE. THE SYRINGE BARREL LABEL WAS REMOVED TO ALLOW FOR A THOROUGH INSPECTION, WHICH REVEALED NO CRACKS OR VISIBLE DAMAGE. THE INTERIOR OF THE BARREL WAS DRY, MAKING IT IMPOSSIBLE TO TEST FOR RESIDUAL SOLUTION. THE SUBMITTED PHOTOGRAPHS SHOWED A SYRINGE WITH THE LABEL INTACT AND THE PLUNGER ROD-RUBBER STOPPER ALSO POSITIONED AT THE 4ML MARK. NO ADDITIONAL INSIGHTS COULD BE OBTAINED FROM THE IMAGES. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR MATERIAL NUMBER 306414, LOT 429958N. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED 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 EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE REPORTED CONDITION HAS BEEN CONFIRMED. HOWEVER, A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

DEVICE EVALUATION IT WAS REPORTED THAT THE HEPARIN SOLUTION IN THE SYRINGE HAD DISAPPEARED. AS A PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE SAMPLE EVALUATION COULD NOT BE CONDUCTED. TO ASSIST IN THE INVESTIGATION, TWO PHOTOGRAPHS WERE PROVIDED FOR ASSESSMENT BY OUR QUALITY TEAM. THE PHOTOGRAPHS DEPICT A SYRINGE WITH THE BARREL LABEL AND THE PLUNGER ROD-RUBBER STOPPER AT THE 4ML GRADUATION SCALE. NO ADDITIONAL INFORMATION COULD BE DERIVED FROM THE PHOTOGRAPHS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE PROVIDED MATERIAL NUMBER 306414, LOT 429958N. THE REVIEW DID NOT REVEAL ANY QUALITY ISSUES DETECTED DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND THE PHOTO SAMPLE ANALYSIS, THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE APPRECIATE YOU BRINGING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND THE REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED IN TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA TO IDENTIFY EMERGING TRENDS.

Description of Event or Problem

THE HEPARIN SOLUTION IN THE SYRINGE HAS DISAPPEARED.