inforMED
MalfunctionOVN

CARDINAL HEALTH

Received Aug 4, 2021 · Event occurred Jun 30, 2021

Report 12273548 · MDR key 12273548

Device

Generic name

Suture Kit

Model number

ACS-S-LAC4

Catalog number

ACS-S-LAC4

Lot number

598878

Product problems

  • Nonstandard Device
  • Product Quality Problem

Patient

22265 DA

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

Narrative

Description of Event or Problem

CARDINAL HEALTH 200, LLC ER LACERATION TRAY HAS BEEN FOUND REPEATEDLY HAVING POOR QUALITY NEEDLE HOLDERS. THE INITIAL ROLL OUT OF THESE ER LACERATION TRAYS HAD NEEDLE HOLDERS THAT DID NOT SECURELY HOLD THE NEEDLE. THE KITS WERE RECALLED, REMOVED, AND REPLACED, BUT THE ISSUE IS STILL OCCURRING. THIS IS THE THIRD KIT THIS WEEK WITH POOR QUALITY NEEDLE HOLDERS. DIFFERENT LOTS HAVE BEEN USED. TODAY'S ISSUE IS WITH LOT #598878. OTHER RESOURCES HAD TO BE UTILIZED LEADING TO DELAY IN CARE/TREATMENT AS A NEW RESOURCE WAS OBTAINED BY THE HEALTH CARE PROVIDERS. IN ADDITION, OBTAINING THE RESOURCE ALSO REQUIRED ADDITIONAL STAFF TO BE PULLED FROM OTHER TASKS, IMPACTING OTHER PATIENTS AS WELL.