MEDLINE

Additional Manufacturer Narrative

UPDATED D4: LOT NUMBER. UPDATED D4: EXPIRATION DATE. UPDATED H4: MANUFACTURING DATE. UPDATED D9: DEVICE AVAILABLE FOR EVALUATION AND DATE RETURNED TO MANUFACTURER. UPDATED H3: DEVICE EVALUATED BY MANUFACTURER. UPDATED H6: TYPE OF INVESTIGATION (B). UPDATED H6: INVESTIGATION FINDINGS (C).

Description of Event or Problem

ACCORDING TO THE CUSTOMER, THE 10 CC SYRINGE FEELS CLOGGED, MEANING YOU CANNOT PUSH IT DOWN WITHOUT CAUSING LEAKING FROM THE PLUNGER.

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, THE 10 CC SYRINGE FEELS CLOGGED, MEANING YOU CANNOT PUSH IT DOWN WITHOUT CAUSING LEAKING FROM THE PLUNGER. NO ADDITIONAL INFORMATION AT THIS TIME. 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.