SITE SCRUB IPA STERILE
Received Jan 10, 2023 · Event occurred Dec 21, 2022
Report 3006260740-2023-00018 · MDR key 16134016
Device
Generic name
Pad, Alcohol, Device Disinfectant
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
3882100
Lot number
JUFU0268
Product problems
- Defective Component
- Defective Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 JUFU0268 SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (JUFU0268) HAVE BEEN REPORTED FROM THE SAME FACILITY. DEVICE NOT RETURNED FOR EVALUATION.
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 THIRD DEVICE.