SAF-T-INTIMA
Received Jul 21, 2026 · Event occurred Jul 2, 2026
Report 3006948883-2026-00482 · MDR key 25893112
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Fever
- Inflammation
Narrative
Description of Event or Problem
IT WAS REPORTED THAT IN THREE PATIENTS OF VARYING AGES, REDNESS, SWELLING, WARMTH, AND INDURATION WERE OBSERVED ON THE BACK OF THE THIGH THREE DAYS AFTER THE INSERTION OF THE ACCESS DEVICE (ON THE FRONT OF THE THIGH). THE ONLY THERAPY ADMINISTERED VIA THE SUBCUTANEOUS ACCESS WAS 500 ML OF ELOMEL ISOTON (ELECTROLYTES). ALL PATIENTS REQUIRED INTRAVENOUS ANTIBIOTICS DUE TO ELEVATED INFLAMMATORY MARKERS AND FEVER. A SURGICAL CONSULTATION WAS ALSO REQUESTED DUE TO A SOFT-TISSUE INFECTION. UNFORTUNATELY, THE SPECIFIC SAF-T-INTIMA DEVICES USED ARE NOT AVAILABLE; HOWEVER, THREE UNITS FROM THE SAME PACKAGE CAN BE SENT IN FOR EXAMINATION. WHEN DID THE INCIDENT OCCUR? DURING USE SHORT DESCRIPTION REDNESS, SWELLING, AND WARMTH ON THE BACKSITE OF THE INSERTION SITE WITH THE BD SAF-T-INTIMA.
Additional Manufacturer Narrative
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.