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

Catalog Number	131151-30C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Irn# (b)(4) this incident took place in france.The department reported an initial failure of the lumbar puncture procedure using a standard introducer.The lumbar.Puncture was subsequently performed using a long atraumatic needle.During needle advancement, bony contact.Occurred.Upon withdrawal, the needle fractured at its midpoint, leaving a fragment in situ.The patient was transferred to the neuroradiology department, where an incision was made to remove the needle fragment under fluoroscopic guidance.The lumbar puncture was then successfully completed under fluoroscopic guidance.Pain at the puncture site was reported following the procedure and was relieved by the administration of 1 g of paracetamol.No other complications have been observed to date.The broken needle fragment was successfully removed under fluoroscopic guidance.
Additional Manufacturer Narrative
Irn# (b)(4) this incident took place in france.Investigations are ongoing.Final evaluation is being transmitted in final report.
Event or Problem Description
Irn#(b)(4) this incident took place in france.The department reported an initial failure of the lumbar puncture procedure using a standard introducer.The lumbar puncture was subsequently performed using a long atraumatic needle.During needle advancement, bony contact occurred.Upon withdrawal, the needle fractured at its midpoint, leaving a fragment in situ.The patient was transferred to the neuroradiology department, where an incision was made to remove the needle fragment under fluoroscopic guidance.The lumbar puncture was then successfully completed under fluoroscopic guidance.Pain at the puncture site was reported following the procedure and was relieved by the administration of 1 g of paracetamol.No other complications have been observed to date.The broken needle fragment was successfully removed under fluoroscopic guidance.
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®
• Common Device Name: SPROTTE®_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: 25885073
• Report Number: 9611612-2026-00020
• Device Sequence Number: 21357041
• Product Code: BSP
• UDI-Device Identifier: 04048223130049
• UDI-Public: 04048223130049
• 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,Followup
• Report Date (Section B): 07/29/2026

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: 131151-30C
• Device Lot Number: 1555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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 Sex: Unknown