MAUDE Adverse Event Report: STRADIS HEALTHCARE HEALTH CARE TECHNOLOGY; CENTRAL LINE KIT

Model Number	HCT541BP-2
Medical Device Problem Codes	Difficult to Open or Remove Packaging Material (2922); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer indicated that the central line kit arrived, where the supplies were placed on the blue"part, which meant that the items were not on a sterile field.However, it should be noted that the both sides of the wrap go through the sterilization process (stradis sterilization load# m20104 at (b)(6)) so in fact there is a sterile field still.
Additional Manufacturer Narrative
The customer complaint indicated normally all of the supplies are on the white part of the sterile field.3/5 kits yesterday had supplies on the blue part which meant you did not have a sterile field.However, due to the eo gas sterilization process, both sides of the csr wrap are sterilized.Upon receipt of the complaint, the impact to the patient was assessed and determined to be a delay in a routine procedure not a life-saving event.Additionally, the issue was determined not to adversely affect the sterile barrier nor the sterility of the contents.Therefore while this issue may have resulted in a treatment delay, it did not increase the patient exposure to non-sterile devices.As a result of the review this was investigated as a customer complaint.It was determined not to qualify as a medical device reportable event.Nor did this assessment indicate that additional field actions were required.During the investigation, a review of the work instructions with assembler indicated the instructions resulted in some confusion indicating the instructions were at the root and may have contributed to quality inspectors failing to detect the errors.The work instructions have since been revised.

• Brand Name: HEALTH CARE TECHNOLOGY
• Common Device Name: CENTRAL LINE KIT
• Manufacturer (Section D): STRADIS HEALTHCARE; 3600 bur wood drive; waukegan IL 60085
• Manufacturer (Section G): STRADIS HEALTHCARE; 3600 bur wood; waukegan IL 60085
• Manufacturer Contact: philip tobin ; 3600 bur wood drive; waukegan, IL 60085 ; 8478878400
• MDR Report Key: 14047452
• Report Number: 1000111025-2022-00002
• Device Sequence Number: 4793610
• Product Code: OFF
• UDI-Device Identifier: M752HCT541BP20
• UDI-Public: M752HCT541BP20
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/12/2022

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: 01/31/2023
• Device Model Number: HCT541BP-2
• Device Catalogue Number: HCT541BP-2
• Device Lot Number: 220040148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown