MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE® 2.G; SPROTTE® 2.G_NEEDLE, CONDUCTION, ANESTHETIC (W/W0 INTRODUCER)

Model Number	021251-29A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint took place in italy.Based on risk assessment and clinical assessment this file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.
Event or Problem Description
(b)(4).Incident occurred in italy: during the insertion of the introducer, after an initial difficulty due to an obstacle (possibly a calcified yellow ligament?), i was able to insert the entire introducer without difficulty.However, i then encountered an inability to advance the introducer needle.Upon removal of the introducer, i found that it had broken.

• Brand Name: SPROTTE® 2.G
• Common Device Name: SPROTTE® 2.G_NEEDLE, CONDUCTION, ANESTHETIC (W/W0 INTRODUCER)
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 21934418
• Report Number: 9611612-2025-00014
• Device Sequence Number: 5228919
• Product Code: BSP
• UDI-Device Identifier: 04048223114858
• UDI-Public: 04048223114858
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K911202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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 Model Number: 021251-29A
• Device Catalogue Number: AA010229
• Device Lot Number: 1558
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• 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: Other
• Patient Sex: Unknown