MAUDE Adverse Event Report: CAREFUSION SPINAL NEEDLE; NEEDLE, SPINAL, SHORT TERM

Model Number	4324ADF
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	04/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Pt was in the process of receiving a myelogram.During one of the attempts at access, the outer portion of the spinal needle became dislodged from the hub and embedded in the soft tissue and required subsequent retrieval.As such, further attempts at access were not performed.Fda safety report id# (b)(4).

• Brand Name: SPINAL NEEDLE
• Common Device Name: NEEDLE, SPINAL, SHORT TERM
• Manufacturer (Section D): CAREFUSION
• MDR Report Key: 8541229
• Report Number: MW5086070
• Device Sequence Number: 400103
• Product Code: MIA
• UDI-Device Identifier: 10885403231834
• UDI-Public: (01)10885403231834
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/18/2019

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: 09/30/2019
• Device Model Number: 4324ADF
• Device Catalogue Number: 4324ADF
• Device Lot Number: 0000718010
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2019
• 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
• Patient Age: 46 YR