0.9% NACL INJECT USP PRE-FILLED SYRINGE

Description of Event or Problem

COMPLAINT/EVENT DESCRIPTION: ON (B)(6) 2026, A REGISTERED NURSE (RN) SUBMITTED A PRODUCT COMPLAINT FORM TO (B)(6) PRODUCT COMPLAINTS VIA FAX TO REPORT THAT BETWEEN (B)(6) 2026, SIX (6) SALINE SYRINGES EXHIBITED SIGNIFICANT RESISTANCE DURING USE. THE RN INDICATED THAT APPROXIMATELY 5 MILLILITERS WERE ABLE TO BE ADMINISTERED FROM EACH SYRINGE BEFORE FLOW CEASED COMPLETELY, PREVENTING FURTHER USE. TWO LOT NUMBERS WERE REPORTED 5301225. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORTS# MW5189395, MW5189396, MW5189397, MW5189399, MW5189400.