IV ADMINISTRATION SET

Description of Event or Problem

ON (B)(6)2025, AND AGAIN ON (B)(6) 2025, I WAS SUBJECTED TO UNSAFE AND POTENTIALLY UNLAWFUL HANDLING OF FDA-REGULATED DRUGS AND DEVICES AT (B)(6). ON (B)(6) 2025, AFTER DIALYSIS, RN "(B)(6)" FORCIBLY ADMINISTERED 0.9% SODIUM CHLORIDE IV SOLUTION (AN FDA-REGULATED PARENTERAL PRODUCT) AGAINST REPEATED REFUSALS BY MANUALLY SQUEEZING THE BAG TO ACCELERATE INFUSION. THIS METHOD OF ADMINISTRATION CONSTITUTES OFF-LABEL USE OF THE DEVICE/DRUG COMBINATION, CREATES A RISK OF EXTRAVASATION, FLUID OVERLOAD, AND CARDIAC INSTABILITY, AND RESULTED IN AN ADVERSE EVENT (TACHYCARDIA ~166 BPM). NO PHYSICIAN ORDER WAS OBTAINED, NO INFORMED CONSENT WAS DOCUMENTED, AND NO ADVERSE EVENT REPORT WAS FILED WITH FDA MEDWATCH AS REQUIRED. THE FORCED ADMINISTRATION OF SALINE IN THIS MANNER RAISES CONCERNS OF MISADMINISTRATION, POTENTIAL PRODUCT ADULTERATION UNDER 21 U.S.C. §351, AND VIOLATION OF POSTMARKETING SAFETY REPORTING OBLIGATIONS. ON (B)(6) 2025, DESPITE A FILED GRIEVANCE REQUESTING REASSIGNMENT, THE SAME RN APPROACHED WITH AN IV SYRINGE CONTAINING AN UNIDENTIFIED, RED-COLORED PARENTERAL PRODUCT. WITHOUT DISCLOSING THE DRUG NAME, VERIFYING PATIENT IDENTITY, OR OBTAINING CONSENT, HE INITIATED AN IV PUSH WHILE SIMULTANEOUSLY HANGING A CALCIUM INFUSION. WHEN I OBJECTED MID-INJECTION, HE ADMITTED HE "FORGOT" MY RESTRICTIONS BUT CONTINUED ADMINISTRATION. THIS EVENT CONSTITUTES AN UNAUTHORIZED DRUG ADMINISTRATION, FAILURE TO VERIFY LABELING, AND POTENTIAL MISBRANDING UNDER 21 U.S.C. §352. THE LACK OF DISCLOSURE AND FAILURE TO DOCUMENT THE DRUG IDENTITY OR MONITOR FOR ADVERSE EFFECTS ALSO VIOLATES 21 CFR §201.57 (LABELING), 21 CFR PART 211 (CGMP FOR FINISHED PHARMACEUTICALS), AND 21 CFR PART 803 (MEDICAL DEVICE REPORTING, GIVEN THAT THE INJECTION WAS DELIVERED THROUGH A REGULATED VASCULAR ACCESS DEVICE). BOTH INCIDENTS REFLECT SYSTEMIC FAILURES IN DRUG HANDLING, DEVICE USE, AND ADVERSE EVENT REPORTING AT (B)(6). THESE PRACTICES CONSTITUTE POTENTIAL MISBRANDING, ADULTERATION, MISADMINISTRATION, AND VIOLATIONS OF FDA POSTMARKETING SAFETY REPORTING REQUIREMENTS. I REQUEST FDA INVESTIGATE (B)(6) COMPLIANCE WITH: 21 CFR PART 211 (DRUG CGMP: LABELING, STORAGE, AND ADMINISTRATION INTEGRITY), 21 CFR PART 201 (LABELING REQUIREMENTS FOR PARENTERAL DRUGS), 21 CFR PART 803 (MEDICAL DEVICE REPORTING, GIVEN ADVERSE EVENTS INVOLVING VASCULAR ACCESS AND SALINE INFUSION), AND 21 CFR §314.80 (POSTMARKETING SAFETY REPORTING OF SERIOUS ADVERSE DRUG EVENTS). THE FAILURE TO DISCLOSE MEDICATION IDENTITY, ADMINISTER SALINE OFF-LABEL BY MANUAL COMPRESSION, COERCE ADMINISTRATION WITHOUT CONSENT, AND FAIL TO REPORT AN ADVERSE TACHYCARDIC EVENT REPRESENT SYSTEMIC BREAKDOWNS IN COMPLIANCE THAT WARRANT FDA REGULATORY INSPECTION AND CORRECTIVE ACTION. DEVICE CODE: 2017.