MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; IN VITRO DIAGNOSTICS

Catalog Number 6801707

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

Patient Problems Exposure to Body Fluids (1745); Eye Injury (1845)

Event Date 12/23/2017

Event Type  Injury  

Manufacturer Narrative

The investigation concluded that waste fluid that may have contained bio hazardous material splashed into the operator¿s eye when emptying vials of vitros calibrator kit 16 and vitros calibrator kit 23 into the laboratory biohazard waste container.The assignable cause of this event is user error, as the vitros operator did not use proper personal protection equipment (safety glasses or face mask) while emptying the fluid into the waste container.Per the vitros calibrator kit 16 and calibrator kit 23 instructions for use: handle as if capable of transmitting disease.This product is prepared from human components.Testing at the individual donor level was nonreactive for hepatitis b surface antigen (hbsag), antibody to hcv, and antibody to hiv using fda approved methods.However, since no test can offer complete assurance that infectious agents are absent, this product should be handled following the recommendations made in clsi guideline m29, or other published biohazard safety guidelines.

Event Description

A customer reported that while discarding the contents of vitros calibrator kits 16 and 23 vials into the laboratory biohazard waste bin, liquid splashed up into the corner of the operator¿s eye from the biohazard waste bin.A splash of clinical laboratory medical waste to the face of a health care worker is considered as blood borne pathogen exposure to skin and mucosa.Due to the unknown pathogen contents and pathogen concentrations in the waste, the potential of infection due to the exposure cannot be ruled out; however the probability of infection should be low.The vitros operator had no adverse reactions or symptoms as a result of this event, and no additional medical treatment was sought.This report is number 2 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.This report corresponds to ortho clinical diagnostics (ortho).(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 1000 lee road; rochester NY 14606
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 7185499
• MDR Text Key: 97109208
• Report Number: 1319808-2018-00004
• Device Sequence Number: 1
• Product Code: JIT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2018
• Device Catalogue Number: 6801707
• Device Lot Number: 2327
• Other Device ID Number: 10758750006717
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other