MAUDE Adverse Event Report: CAREFUSION 2200, INC SAFE-T; LUMBAR PUNCTURE TRAY (ADULT & PEDIATRIC)

Model Number	4306CWSP
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Foam needle stop was not adhered to the bottom of the tray, so it came out when needle was placed in it.22-gauge needles in use.Staff member put the plastic cap flat on the tray and slid the needle in.She moved the needle vertically to secure the cap and the cap poked through the top of the plastic cap.Employee needlestick injury occurred.Two prior incidents with this lot did not result in employee injury.Manufacturer response for lumbar puncture tray (adult pediatric), safe-t (per site reporter)."i will be forwarding this on to our field assurance team.Even though we are no longer selling this item, we do indeed need to be made of any adverse events.Thank you.".

• Brand Name: SAFE-T
• Common Device Name: LUMBAR PUNCTURE TRAY (ADULT & PEDIATRIC)
• Manufacturer (Section D): CAREFUSION 2200, INC; 1625 w. 3rd street; tempe AZ 85281
• MDR Report Key: 16234216
• Report Number: 16234216
• Device Sequence Number: 20550640
• Product Code: PWY
• UDI-Device Identifier: 10885403229008
• UDI-Public: (01)10885403229008
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 01/23/2023
• Report Date (Section F): 01/23/2023

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: 4306CWSP
• Device Catalogue Number: 4306CWSP
• Device Lot Number: 0001482141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2023
• 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
• Patient Weight: 95 KG
• Date Report Sent to FDA: 01/23/2023