SYRINGE 5ML HEPARIN 10 UNIT

Additional Manufacturer Narrative

PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THE SYRINGE HAD AIR AND NO FLUID. TO AID IN THE INVESTIGATION, TWO SAMPLES WITH NO PACKAGING FLOW WRAPS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SAMPLES ARE EMPTY. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS CONDITION OCCURS IF THERE IS A JAM DURING THE SYRINGE FILLING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306414, LOT 429953N. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES 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. THE SAMPLES WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

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

MATERIAL # 306414 BATCH #4 29953N THERE HAS BEEN ANOTHER REPORT TODAY OF THE SAME ISSUE WITH THE SAME LOT NUMBER. I ALSO HAVE THAT FOR RETURN. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED BD POSIFLUSH PREFILLED HEPARIN LOCK FLUSH SYRINGE, 5 ML SYRINGE 5 ML HEPARIN FILL, 10 USP UNITS/ML, SKU 306414. A SYRINGE WAS NOTED TO HAVE AIR IN THE SYRINGE AND NO FLUID/HEPARIN. THE USER NOTED THE ABSENCE OF FLUID UPON OPENING AND PRIMING FOR INSTALLATION INTO AN ARTERIAL LINE IN THE NICU. NO LEAK NOTED. ITEM SAVED AND AVAILABLE FOR RETURN. LOT NUMBER 429953N, EXPIRATION DATE OF 04/30/2026. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO HARM. DEFECT DISCOVERED PRIOR TO ADMINISTERING TO PATIENT.