MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number TN,DXH SLIDEMAKER STAINER II

Device Problem Sharp Edges (4013)

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

Event Date 03/16/2021

Event Type  Injury  

Manufacturer Narrative

There was no impact to patients as a result of this event.The fse had a battery of tests performed for possible infectious diseases on the same day of the cut, all tests had negative results.The fse was prescribed a prophylaxis cocktail (dulotegravir sodium and tenofovir desaproxil fumarate + lumivudine).Besides the initial baseline testing, the fse will have additional testing at scheduled intervals to monitor his health.Bec internal identifier - (b)(4).

Event Description

The field service engineer (fse) reported that while working on the dxh sms instrument he received a small cut on his left thumb from a broken slide.At the time of the injury the fse was wearing personal protective equipment (ppe) which included gloves.The slide may contain biohazardous material from patient samples.

• Brand Name: UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 11641239
• MDR Text Key: 245925029
• Report Number: 1061932-2021-00058
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590701567
• UDI-Public: (01)15099590701567(11)190401
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K162414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TN,DXH SLIDEMAKER STAINER II
• Device Catalogue Number: C11477
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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