MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS RE CONTROLS; IN-VITRO DIAGNOSTICS

Catalog Number	1009406
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body Sensation in Eye (1869)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation concluded that a vitros operator experienced left eye pain caused by glass dust that may have entered his left eye, produced by a shattered glass bottle of vitros reproductive endocrine (re) controls.The re control vial broke when the operator tapped the vial on the benchtop to dislodge lyophilate.The glass vial shattered and the bottom of the vial turned to a glass dust, not shards, which the operator suspected got into his eye.The operator was wearing a lab coat, nitrile gloves, and safety glasses.The vitros re control ifu does not indicate to dislodge the lyophilate by gently tapping the vial on a hard surface.Therefore, user error likely contributed to this event.
Event or Problem Description
The ortho clinical diagnostics (ortho) technical solution center (tsc) was contacted to report a vitros operator experienced left eye pain potentially caused by glass dust that may have entered his left eye, produced by a shattered glass bottle of vitros reproductive endocrine (re) controls.The operator immediately rinsed his eye with water and then sought medical treatment.The eye doctor was able to verify that the eye, though inflamed, did not contain any foreign material and did not looked damaged from scratching.Per medical consultation from medical safety officer (b)(6) dated (b)(6) 2024: per the sds, the re control contains human plasma, human cord serum/plasma, and kathon (a chemical mixture).Due to the presence of human blood and blood products, there exists the risk of transmission of blood-borne pathogens upon exposure to the body mucosa.Donors and donation blood for ortho reagents tested negative per current fda-required tests; therefore, the chance of being transmitted with the common blood-borne pathogens is low.However, no test can guarantee 100% detection.So, for precaution, this case is classified as serious injury.The reagent is also listed as an eye irritant, which the operator may have experienced.The necessary first aid measure includes immediate rinse with water, which was done in this case.Medical care was supportive, with no active management for inflammation.Based on the description, it appears that the operator may have suffered a mild allergic reaction.Therefore, serious long-term injury due to the allergic reaction is not anticipated.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment 607141.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS RE CONTROLS
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 20080639
• Report Number: 3007111389-2024-00164
• Device Sequence Number: 12703815
• Product Code: JJY
• UDI-Device Identifier: 10758750008322
• UDI-Public: (01)10758750008322(17)260127(11)240310(10)0890
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2026
• Device Catalogue Number: 1009406
• Device Lot Number: 0890
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown