POWER LINK SYSTEM
Received Oct 4, 2022 · Event occurred Sep 8, 2022
Report 2050012-2022-00055 · MDR key 15540320
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Beckman CoulterModel number
POWER LINKCatalog number
B05033
Lot number
N/A
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PLEASE REFER TO INVESTIGATION RESULTS SECTION FOR INVESTIGATION DETAILS.
Description of Event or Problem
THE CUSTOMER REPORTED AN INJURY WHILE OPERATING THE POWER LINK SYSTEM. THE CUSTOMER WAS PERFORMING MAINTENANCE ON THEIR SYSTEM, AND WHILE REMOVING THE SAMPLE FROM THE GRIPPER, THE CUSTOMER CUT THE FINGER ON THE POWERLINK INLET METAL PLATE. IT WAS KNOWN THAT THE CUSTOMER DID NOT WEAR GLOVES AT THE TIME OF THE INCIDENT. DUE TO SERUM RESIDUE SEEN ON THE METAL PLATE, CUSTOMER FOLLOWED THEIR OCCUPATIONAL HEALTH NEEDLESTICK GUIDELINES AND SOUGH MEDICAL ATTENTION. THE CUSTOMER RECEIVED FIRST AID KIT FOR LOCAL DRESSING. CUSTOMER ALSO RECEIVED HEPATITIS B SHOT VACCINATION. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT. AS OF (B)(6) 2022, NO ADDITIONAL INFORMATION WAS PROVIDED.