inforMED
MalfunctionOGJ

NERVE BLOCK TRAY FACET-LF

Received Apr 30, 2024 · Event occurred Apr 2, 2024

Report 1417592-2024-00553 · MDR key 19215652

Device

Generic name

Nerve Block Tray Facet-lf

Catalog number

DYNJRA0207A

Lot number

24BBO038

Product problems

  • Appropriate Device Problem Term/Code Not Available
  • Appropriate Device Problem Term/Code Not Available

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

ACCORDING TO THE CUSTOMER, "THE 20 ML SYRINGE AS SOME TYPE OF PARTICLE WAS FOUND BETWEEN THE BARREL AND PLUNGER OF THE SYRINGE THAT HAS CAUSED A CONCERN WITH THE PRACTICING CLINICIAN".

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, "THE 20 ML SYRINGE AS SOME TYPE OF PARTICLE WAS FOUND BETWEEN THE BARREL AND PLUNGER OF THE SYRINGE THAT HAS CAUSED A CONCERN WITH THE PRACTICING CLINICIAN". THERE WAS NO FURTHER INFORMATION. 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.