inforMED
MalfunctionNGT

POSIFLUSH

Received Dec 10, 2025 · Event occurred Nov 20, 2025

Report 3002682307-2025-00137 · MDR key 23768629

Device

Generic name

Saline Vascular Access Flush

Catalog number

306575

Lot number

UNKNOWN

Product problems

  • Filling Problem
  • Filling Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

INVESTIGATION RESULTS: A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS NO BATCH/LOT NUMBER WAS MADE AVAILABLE FOR THIS REPORTED EVENT. A DHR REVIEW COULD NOT BE PERFORMED AS NO BATCH/LOT NUMBER WAS MADE AVAILABLE FOR THIS REPORTED EVENT. A REVIEW OF THE APPLICABLE RISK DOCUMENT INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION. ROOT CAUSE COULDN'T BE DETERMINED DUE TO UNAVAILABILITY OF SAMPLE/MATERIAL/LOT NUMBER INFORMATION.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

Description of Event or Problem

PER REPORTER "2 BOXES DID NOT INCLUDE SODIUM CHLORIDE SOLUTION IN IT." PATIENT INJURY: NO. BEFORE USE.