SYRINGE 5ML HEPARIN 10 UNIT

Additional Manufacturer Narrative

(B)(6) FOLLOW UP. IT WAS REPORTED THE SYRINGE HAD AIR IN IT AND LACKED HEPARIN FLUID. OUR QUALITY TEAM HAS COMPLETED A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER 306414 AND LOT NUMBER 434180N. THE REVIEW DID NOT IDENTIFY ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE DEFECT, AND ALL QUALITY TESTS WERE WITHIN SPECIFICATION. DUE TO THE UNAVAILABILITY OF A SAMPLE FOR RETURN, A COMPREHENSIVE SAMPLE INVESTIGATION COULD NOT BE CONDUCTED. SHOULD YOU ENCOUNTER ANY FURTHER ISSUES WITH OUR PRODUCT, WE WOULD APPRECIATE THE OPPORTUNITY TO PERFORM A DETAILED ANALYSIS.

Description of Event or Problem

MATERIAL #306414, BATCH # 434180N. IT WAS REPORTED BY THE CUSTOMER THAT THE SYRINGE LACKED HEPARIN/FLUID. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. SHARING TWO ADDITIONAL EVENTS OF AIR IN SYRINGE AND LACK OF HEPARIN/FLUID. THESE WERE NOT SAVED FOR RETURN. ASKING FOR ADDITIONAL INVESTIGATION INTO THE MANUFACTURING DEFECT. THE CLOSURE LETTERS I RECEIVED FOR THE PRIOR EVENTS STATE NO ISSUES WITH THE PRODUCTION PROCESS BUT THIS IS AN INCREASING SAFETY TREND FOR THIS PRODUCT. EVENT DATE: 4/18/2025. REF 306414. LOT 434180N. EXP 2026-06-30. EVENT DATE: 4/19/2025. REF 306414. LOT 43410N. EXP 2026-06-30.

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.