inforMED
MalfunctionFOX

STATLOCK MULTI-PURPOSE 5IN TRICOT

Received Jun 25, 2024 · Event occurred May 31, 2024

Report 3006260740-2024-03243 · MDR key 19610860

Device

Generic name

Stand, Infusion

Model number

N/A

Catalog number

MP0120

Lot number

UNKNOWN

Product problems

  • Defective Component
  • Defective Component

Patient

NA · Unknown

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

Narrative

Additional Manufacturer Narrative

H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

Description of Event or Problem

IT WAS REPORTED BY THE CUSTOMER THAT THE TAGS' SHARPNESS TENDS TO CUT THE CHEST TUBE WHILE SECURING IT, AND IT IS VERY DIFFICULT TO REOPEN AND READJUST THE CHEST TUBE. NO OTHER INFORMATION WAS PROVIDED.