10ML 0.9% NACL INJECT USP PFS

Description of Event or Problem

ON (B)(6) 2026, A CLINIC MANAGER REPORTED WE HAVE IDENTIFIED A RECURRING AND SERIOUS SAFETY ISSUE INVOLVING TULIP FISTULA NEEDLES AND ASSOCIATED SYRINGES. ON MULTIPLE OCCASIONS. THE LURE TIP HAS BROKEN OFF IN THE LINE DURING FLUSHING. THIS HAS OCCURRED AT LEAST TWICE, RESULTING IN THE NEED FOR ADDITIONAL NEEDLE PLACEMENTS (A TOTAL OF THREE EXTRA NEEDLE INSERTIONS). THIS PRESENTS A SIGNIFICANT PATIENT SAFETY RISK AND CAUSES UNNECESSARY TRAUMA. ADDITIONALLY, SEVERAL SYRINGES HAVE BEEN FOUND TO HAVE VISIBLE CRACKS AND LEAKS. DURING ASPIRATION, BLOOD HAS BEEN OBSERVED LEAKING FROM THESE CRACKS, COMPROMISING STERILITY AND INCREASING THE RISK OF EXPOSURE AND CONTAMINATION. THESE ISSUES HAVE AFFECTED MULTIPLE PATIENTS OVER THE PAST TWO WEEKS AND REPRESENT A CONSISTENT PATTERN RATHER THAN ISOLATED INCIDENTS. KEY CONCERNS: LUER TIP DETACHMENT DURING FLUSHING; CRACKED SYRINGES LEADING TO LEAKAGE; BLOOD EXPOSURE DURING ASPIRATION; MULTIPLE PATIENTS IMPACTED; NEED FOR REPEATED NEEDLE INSERTIONS DUE TO DEVICE FAILURE. THIS MATTER REQUIRES IMMEDIATE INVESTIGATION. WE RECOMMEND: REMOVING AFFECTED PRODUCT BATCHES FROM USE IMMEDIATELY; NOTIFYING THE MANUFACTURER; REPORTING TO APPROPRIATE REGULATORY AND PATIENT SAFETY BODIES; REVIEWING CURRENT INVENTORY FOR DEFECTS. PLEASE TREAT THIS AS AN URGENT PATIENT SAFETY ISSUE. DEVICE CODE: 1069; 1135; 1250; 2936. PATIENT CODE: 4580. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORT#: MW5187317.