inforMED
MalfunctionLKB

SITE SCRUB IPA STERILE

Received Jan 10, 2023 · Event occurred Dec 21, 2022

Report 3006260740-2022-06034 · MDR key 16133695

Device

Generic name

Pad, Alcohol, Device Disinfectant

Model number

N/A

Catalog number

3882100

Lot number

JUFR2096

Product problems

  • Defective Component
  • Defective Component

Patient

Unknown

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

Narrative

Description of Event or Problem

IT WAS REPORTED BY THE CUSTOMER ¿THE SITE SCRUBS HAVE BEEN FOUND TO BE COMPLETELY DRY UPON OPENING THEM.¿ NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

Additional Manufacturer Narrative

THE DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUFR2096 SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (JUFR2096) HAVE BEEN REPORTED FROM THE SAME FACILITY.