MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE STANDARD SPROTTE NEEDLE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Model Number 331151-31B

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2023

Event Type  malfunction  

Event Description

Plastic hub broke off metal shaft when attempting to remove lumbar puncture (lp) needle from patient.Required forceps to extract metal shaft.Metal shaft removed with forceps.

• Brand Name: STANDARD SPROTTE NEEDLE
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; 4575 marconi dr; alpharetta GA 30005
• MDR Report Key: 18739711
• MDR Text Key: 335763483
• Report Number: 18739711
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/11/2023

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: 331151-31B
• Device Catalogue Number: 331151-31B
• Device Lot Number: 1478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2023
• Date Report to Manufacturer: 02/20/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/20/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1