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

Model Number 405181

Device Problem Fluid/Blood Leak (1250)

Patient Problem Discomfort (2330)

Event Date 01/18/2023

Event Type  malfunction  

Event Description

During patient peng (pericapsular nerve group block) peripheral nerve block, 22gx3.5in spinal needle began leaking where the needle joins the clear hub of the needle.It was not a loose connection at the luer lock above where the needle is screwed onto the extension tubing.Anesthesia had to stop nerve block procedure, replace the needle, then poke the patient again.As a result, patient reported discomfort with each poke.

• Brand Name: SPINAL NEEDLE QUINCKE TYPE POINT
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 16292308
• MDR Text Key: 308729012
• Report Number: 16292308
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2023

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
• Device Operator: Health Professional
• Device Model Number: 405181
• Device Catalogue Number: 405181
• Device Lot Number: 1274747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5840 DA
• Patient Weight: 59 KG
• Patient Race: White