MalfunctionLKB
SITE SCRUB IPA STERILE
Received Sep 17, 2021 · Event occurred Aug 23, 2021
Report 3006260740-2021-03886 · MDR key 12492522
Device
Generic name
Pad, Alcohol, Device Disinfectant
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Catalog number
3882100
Lot number
JUEV0567
Product problems
- Defective Component
- Defective Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUEV0567 SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER HAVE BEEN REPORTED FROM THE SAME FACILITY.
Description of Event or Problem
IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THREE KITS WERE OPENED FOR A CLASS AND THE SITE SCRUB WAS DRY IN ALL OF THEM. THIS REPORT ADDRESSES THE SECOND DEVICE.