MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE INFILTRALONG

Catalog Number	001158-30C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Irn# (b)(4).Incident occurred in netherlands.Tentative translation: catheter torn off and 7 cm left in patient which will be removed after wound healed.
Additional Manufacturer Narrative
Investigations are ongoing.Final evaluation can be found in following report.
Event or Problem Description
Irn# (b)(4).Incident occurred in netherlands.Tentative translation: catheter torn off and 7 cm left in patient which will be removed after wound healed.
Additional Manufacturer Narrative
Update 2026-02-16: imdrf codes have been updated and the results of investigation have been updated.This case is considered as closed.If further information becomes available an update will be sent to the agency.

• Brand Name: INFILTRALONG
• Common Device Name: INFILTRALONG
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer Contact: armin pfeifer ; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• MDR Report Key: 23644791
• Report Number: 9611612-2025-00048
• Device Sequence Number: 21289367
• Product Code: BSO
• UDI-Device Identifier: 04048223130834
• UDI-Public: 04048223130834
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K080675
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 001158-30C
• Device Lot Number: 1497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• 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: Other
• Patient Sex: Unknown