MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE® 2.G; SPROTTE® 2.G_NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number	021251-30A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Irn# (b)(4).This incident took place in france.23-year-old patient hospitalized for investigation of intracranial hypertension.An attempt at lumbar puncture was made on (b)(6) 2026 with premedication using 20 mg of seresta and application of an emla patch approximately 30 minutes before the procedure.Skin preparation was performed with soap followed by chlorhexidine.A 24g violet needle was used.Despite a properly conducted procedure, it was impossible to reach the vertebrae (bmi: 39.96).The needle was inserted almost up to the hub, and withdrawal of the stylet proved difficult; it was eventually removed, twisted at its tip.Removal of the needle showed that it was split in its distal third.A lumbar spine x-ray was performed, confirming that a 6.62 mm fragment of the needle remained at the level of the l4-l5 interspinous space.Removal of the needle fragment was carried out under general anesthesia by a neurosurgeon on (b)(6) 2026.
Additional Manufacturer Narrative
Irn# (b)(4).This incident took place in france.This case is considered as closed.If further information becomes available an update will be send to the agency.

• Brand Name: SPROTTE® 2.G
• Common Device Name: SPROTTE® 2.G_NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-württemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-württemberg 78187 ; GM 78187
• Manufacturer Contact: armin pfeifer ; karl-hall-str. 1; geisingen, baden-württemberg 78187 ; GM 78187
• MDR Report Key: 25824574
• Report Number: 9611612-2026-00016
• Device Sequence Number: 9721036
• Product Code: BSP
• UDI-Device Identifier: 04048223112052
• UDI-Public: 04048223112052
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K241953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 021251-30A
• Device Lot Number: 1479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 23 YR
• Patient Sex: Female