inforMED
MalfunctionDXT

SYRINGE,10ML,TR/FR,MLL,W/RES

Received Dec 23, 2025 · Event occurred Nov 12, 2025

Report 3015910259-2025-00114 · MDR key 23878713

Device

Generic name

Syringe,10ml,tr/fr,mll,w/res

Catalog number

70085003

Lot number

0000075375

Product problems

  • Connection Problem
  • Connection Problem

Patient

NA · Unknown

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

Narrative

Additional Manufacturer Narrative

UPDATE TO H6: INVESTIGATION FINDINGS (C). UPDATE TO H6: INVESTIGATION CONCLUSIONS (D).

Additional Manufacturer Narrative

IT WAS REPORTED THAT ON (B)(6) 2025 THE SYRINGE "COULD NOT BE CONNECTED TO THE MANIFOLD." THE CUSTOMER REPORTED THE ISSUE OCCURRED "DURING THE PREPARATION STAGE" AND THAT THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER STATED THAT "OTHER PRODUCTS WERE USED" AND THAT "IT IS SUSPECTED THAT THE USER IS USING IT INCORRECTLY." TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN 1417592 ON 22-JAN-2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2025 THE SYRINGE "COULD NOT BE CONNECTED TO THE MANIFOLD." THE CUSTOMER REPORTED THE ISSUE OCCURRED "DURING THE PREPARATION STAGE" AND THAT THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER STATED THAT "OTHER PRODUCTS WERE USED" AND THAT "IT IS SUSPECTED THAT THE USER IS USING IT INCORRECTLY."