MAUDE Adverse Event Report: PAJUNK GmbH Medizintechnologie EpiSpin Safety NRFit, Tuohy NRFit; EpiSpin Safety NRFit, Tuohy NRFit _Anesthesia Conduction Kit

Catalog Number	1022461-30
Medical Device Problem Codes	Break (1069); Fitting Problem (2183)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Irn# (b)(4) this incident took place in france (polynésie).An epidural catheter was to be inserted in case additional anesthetic dosing became necessary and to provide postoperative epidural analgesia.After completion of the spinal anesthesia, an attempt was made to withdraw the spinal needle (sprotte) from the epidural needle (tuohy).The metallic portion of the spinal needle remained lodged inside the epidural needle while both were still in the patient's back, with no possibility of grasping it.The plastic hub of the spinal needle, to which the injection syringe is attached and locked, detached and fell to the floor.As there was no longer any external access point to the metallic portion of the spinal needle, it became necessary to remove the epidural needle in order to safely withdraw the spinal needle from the patient's back.Consequently, it was no longer possible to use the epidural needle to thread an epidural catheter and administer additional anesthetic doses should the surgical procedure be prolonged, nor to provide postoperative epidural analgesia.).
Additional Manufacturer Narrative
Rn# (b)(4).This incident took place in france ( polynésie).This case is considered as closed.If further information becomes available an update will be send to the agency.

• Brand Name: EpiSpin Safety NRFit, Tuohy NRFit
• Common Device Name: EpiSpin Safety NRFit, Tuohy NRFit _Anesthesia Conduction Kit
• 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: karl-hall-str. 1; geisingen, baden-württemberg 78187
• MDR Report Key: 50913372
• Report Number: 9611612-2026-00022
• Device Sequence Number: 14794984
• Product Code: CAZ
• UDI-Device Identifier: 04048223074800
• UDI-Public: 04048223074800
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060563
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 1022461-30
• Device Lot Number: 1530
• 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: 09/07/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown