MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC IV START 1624 1ML CHL; KIT, I.V. START

Model Number	01-9001A
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Registered nurse (rn) starting iv went to cleanse forearm with chloraprep.While applying chloraprep applicator to skin, rn pinched tubes to release fluid into skin.Sponge top fell off and glass shards grazed skin superficially.Skin re-cleansed and band-aid applied.Doctor at bedside to witness.

• Brand Name: IV START 1624 1ML CHL
• Common Device Name: KIT, I.V. START
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 17820648
• Report Number: 17820648
• Device Sequence Number: 20367963
• Product Code: LRS
• UDI-Device Identifier: 10887488176512
• UDI-Public: (01)10887488176512
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2023
• Report Date (Section F): 09/08/2023

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 Model Number: 01-9001A
• Device Catalogue Number: 01-9001A
• Device Lot Number: 010580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 09/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 09/08/2023