MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1; IN-VITRO DIAGNOSTICS

Catalog Number	1882208
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that when attempting to remove the aluminum cap of a vitros calibrator kit 1, the vial broke, and the operator sustained a small cut to the hand.The operator was wearing a latex glove at the time of the incident.First aid was provided, including removing the glass splinter, wound cleansing, and bandaging.There was no further medical treatment at the time of the event.Upon follow-up with the customer, the operator stated they were okay and that the wound had already healed.Additionally, no further medical treatment was required for the operator.
Event or Problem Description
A laboratory operator sustained a small cut to their hand when attempting to open vial 2 of vitros calibrator kit 1.There was no allegation of a serious or long term permanent injury.However, there is a potential that the operator might be exposed to blood borne pathogens and should be considered as a serious injury.Per medical consult from an ortho medical safety officer: based on the safety data sheet, there is a risk of zoonotic infection from contact with animal blood derivatives.Although the materials for making the reagents were tested negative for blood-borne pathogens, no test method can assure that the product is completely safe from potential pathogens.In addition, there might be unknown pathogens or pathogens that were not tested.So, a disease transmission due to the exposure cannot be excluded.Thus, this event meets the definition of a serious injury due to the uncertainty of infection risk.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
• 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, INC.; 1000 lee road; rochester NY 14606
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18367912
• Report Number: 0001319808-2023-00021
• Device Sequence Number: 7617724
• Product Code: JIX
• UDI-Device Identifier: 10758750000166
• UDI-Public: 10758750000166
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2024
• Device Catalogue Number: 1882208
• Device Lot Number: 0152
• 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: 11/27/2023
• Initial Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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