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

Model Number 01-96001A

Device Problems Detachment of Device or Device Component (2907); Sharp Edges (4013)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/15/2021

Event Type  malfunction  

Event 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
• Type of Device: I.V. START KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 12452567
• MDR Text Key: 270786352
• Report Number: 12452567
• Device Sequence Number: 1
• Product Code: LRS
• UDI-Device Identifier: 10887488494029
• UDI-Public: (01)10887488494029
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-96001A
• Device Catalogue Number: 01-96001A
• Device Lot Number: 0255145
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/27/2021
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other