SITE SCRUB IPA STERILE
Received Jul 29, 2021 · Event occurred Jun 22, 2021
Report 3006260740-2021-03005 · MDR key 12247035
Device
Generic name
Pad, Alcohol, Device Disinfectant
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
3882100
Lot number
JUEV0549
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 JUEV0549 SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem
IT WAS REPORTED THE BARD SITE SCRUB COMPONENT WITHIN THE KIT HAS BEEN COMING UP DRY. NO DELAY IN PROCEDURES, ANOTHER KIT WOULD BE OPENED AND USED OR INJURY/MEDICAL TREATMENT AS A RESULT. IT WAS STATED THIS OCCURRED AT LEAST THREE TIMES. NO OTHER INFORMATION REGARDING QUANTITY OR OCCURRENCES WAS PROVIDED. THIS REPORT ADDRESSES THE THIRD OCCURRENCE.