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

Model Number POWER LINK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2022

Event Type  Injury  

Manufacturer Narrative

Please refer to investigation results section for investigation details.

Event 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
• Type of Device: 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
• MDR Text Key: 301151446
• Report Number: 2050012-2022-00055
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590583996
• UDI-Public: (01)15099590583996(11)141001
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other