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

Model Number 4324ADF

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 04/11/2019

Event Type  malfunction  

Event 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
• Type of Device: NEEDLE, SPINAL, SHORT TERM
• Manufacturer (Section D): CAREFUSION
• MDR Report Key: 8541229
• MDR Text Key: 142955467
• Report Number: MW5086070
• Device Sequence Number: 1
• Product Code: MIA
• UDI-Device Identifier: 10885403231834
• UDI-Public: (01)10885403231834
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR