MAUDE Adverse Event Report: BECKMAN COULTER BIOMEDICAL GMBH RECAPPER; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number RECAPPER RETROFIT KIT, MUNSELL (WHITE), FOR UPGRADING WITH R

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 04/28/2022

Event Type  malfunction  

Event Description

The customer reported an incident with the automate instrument.A laboratory technician had injured herself (cut her index finger) while cleaning the recapper.The technician's index finger of her left hand had been cut up to the nail.The injury was treated with "emergency measures" in the laboratory.The technician was treated by the emergency surgery and blood was drawn for hepatitis/hiv analysis.The lab technician did not receive any medication and was not at work for one (1) day sick leave.

Manufacturer Narrative

Beckman coulter field service engineer (fse) evaluated the au5800 chemistry analyzer, the fse determined that the safety slice of the blade was disassembled by the customer, and the safety cover of the knife had not been reattached.The cause of the issue is attributed to use error.(b)(6).The beckman coulter internal identifier is (b)(4).

• Brand Name: RECAPPER
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER BIOMEDICAL GMBH; sauerbruchstr. 50; münchen 81377 ; GM 81377
• Manufacturer (Section G): BECKMAN COULTER BIOMEDICAL GMBH; sauerbruchstr. 50; munich 81377 ; GM 81377
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821
• MDR Report Key: 14415680
• MDR Text Key: 300089570
• Report Number: 3006655511-2022-00003
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 15099590362119
• UDI-Public: (01)15099590362119(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• 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: 05/16/2022

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: RECAPPER RETROFIT KIT, MUNSELL (WHITE), FOR UPGRADING WITH R
• Device Catalogue Number: ODL20622
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other