SITE SCRUB IPA STERILE
Received Apr 15, 2022 · Event occurred Mar 23, 2022
Report 3006260740-2022-01319 · MDR key 14118182
Device
Generic name
Pad, Alcohol, Device Disinfectant
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
3882100
Lot number
UNKNOWN
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 "DRY SITE SCRUB WAS FOUND IN THE KIT. THIS PRODUCT BEING DRY IS A SERIOUS INFECTION RISK. THE ISSUE IS THAT THE SITE SCRUB HAD BEEN OPENED."
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) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT. DEVICE NOT RETURNED FOR EVALUATION.