MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; I.V. START KIT

Model Number	01-96001A
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient to receive contrast for his mri exam.Was starting his iv, used the applicator prep provided in iv start kit.The sponge head of prep applicator came off while prepping the iv site.Small shards of glass from the applicator nicked patients skin.

• Brand Name: CARDINAL HEALTH
• Common Device Name: I.V. START KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 12452567
• Report Number: 12452567
• Device Sequence Number: 3964245
• Product Code: LRS
• UDI-Device Identifier: 10887488494029
• UDI-Public: (01)10887488494029
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/27/2021
• Report Date (Section F): 08/27/2021

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: 01-96001A
• Device Catalogue Number: 01-96001A
• Device Lot Number: 0255145
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/10/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 08/27/2021