MAUDE Adverse Event Report: HOLOGIC, INC. PROCLEIX DEACTIVATION BUFFER; IN-VITRO DIAGNOSTIC

Catalog Number 303666

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Chemical Exposure (2570)

Event Date 06/09/2016

Event Type  Injury  

Event Description

(b)(6) operator was splashed in the eye with deactivation fluid.The operator was wearing full ppe including eye protection at the time of the incident.The operator washed her eye for 15 minutes with the emergency eye wash station on-site.Her eye was still stinging, so was taken to the emergency room where she had a 1 hour 'slow drop' saline wash.Fse (field service engineer) visited the (b)(6) to gather information on the incident.The operator had lifted the bottle to her eye level as she attempted to lift it over a system fluid bottle that was at the chest level.The bottle was dropped twice from a short distance of a few inches (once in the instrument and again on the trolley).The lab fully acknowledges that their own procedural actions lead to this event.The bottles failure mode was a drop from height with fluid, not a stress over time failure.The safety data sheet states that tight sealing safety googles should be worn handling deactivation buffer.

• Brand Name: PROCLEIX DEACTIVATION BUFFER
• Type of Device: IN-VITRO DIAGNOSTIC
• Manufacturer (Section D): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: anila tarte ; 10210 genetic center drive; san diego, CA 92121 ; 8584108055
• MDR Report Key: 5780513
• MDR Text Key: 49128902
• Report Number: 2024800-2016-00019
• Device Sequence Number: 1
• Product Code: JCC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2016

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: No Information
• Device Catalogue Number: 303666
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 07/09/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention