MAUDE Adverse Event Report: BECKMAN COULTER POWER LINK SYSTEM; RADIOASSAY, VITAMIN B12

Model Number	POWER LINK
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please refer to investigation results section for investigation details.
Event or Problem Description
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.

• Brand Name: POWER LINK SYSTEM
• Common Device Name: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821-8000 ; 7149613625
• MDR Report Key: 15540320
• Report Number: 2050012-2022-00055
• Device Sequence Number: 6107586
• Product Code: CDD
• UDI-Device Identifier: 15099590583996
• UDI-Public: (01)15099590583996(11)141001
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: POWER LINK
• Device Catalogue Number: B05033
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown