inforMED
MalfunctionNGT

POSIFLUSH

Received Jun 15, 2026 · Event occurred Jun 7, 2026

Report 1911916-2026-00306 · MDR key 25502800

Device

Generic name

Saline, Vascular Access Flush

Catalog number

306546

Lot number

6096367

Product problems

  • Device Contamination with Chemical or Other Material

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. G.4. ADDITIONAL 510K: K141311;K250884.

Description of Event or Problem

IT WAS REPORTED, SYRINGE 10ML REG PR SALINE 10ML FILL, FOREIGN MATTER. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: HAS LARGE BLACK SPECK IN SYRINGE. TOTAL NUMBER OF OCCURRENCES: 2. WAS THE PATIENT IMPACTED? DID NOT USE. WAS ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO A HEALTHCARE PROFESSIONAL? NO.