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

Model Number	511151-29A
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Irn# (b)(4).Complaint took place in sweden.This incident did not take place in the usa, but as co-reported.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
Irn# (b)(4).Incident occurred in sweden: the needle came off/disconnected from the cannula holder, see attached picture.The needle remained in the patient, barely 1 cm of the needle was visible at that time.

• 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-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: 21887853
• Report Number: 9611612-2025-00010
• Device Sequence Number: 17004859
• Product Code: BSP
• UDI-Device Identifier: 04048223116753
• UDI-Public: 04048223116753
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/23/2025

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: 511151-29A
• Device Catalogue Number: 511151-29A
• Device Lot Number: 1527
• 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: 03/20/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown