MAUDE Adverse Event Report: BD BD SPINAL NEEDLE QUINCKE TYPE POINT; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Lot Number	9274342
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Pt needed a lumbar puncture (lp).The bd spinal needle that was going to be used for the lp has a hair stuck in the unopened package.Fda safety report id# (b)(4).

• Brand Name: BD SPINAL NEEDLE QUINCKE TYPE POINT
• Common Device Name: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): BD
• MDR Report Key: 9616088
• Report Number: MW5092372
• Device Sequence Number: 585226
• Product Code: BSP
• UDI-Device Identifier: 00382904051846
• UDI-Public: (01)00382904051846
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2020

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: 09/30/2024
• Device Lot Number: 9274342
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1