MalfunctionNGT

POSIFLUSH

Received Jun 26, 2026 · Event occurred Jun 1, 2026

Report 1911916-2026-00352 · MDR key 25637160

Device

Generic name

Saline, Vascular Access Flush

Manufacturer

Bd Medical (bd West) Medical Surgical

Catalog number

306546

Lot number

6085955

Product problems

Contamination

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED, SYRINGE 10 ML REG PR SALINE, FOREIGN MATTER-MOLD. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE SALINE FLUSHES WAS FOUND WITH MOLD.