MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE INFILTRALONG SET 700; INFILTRALONG SET 700_CATHETER, CONDUCTION, ANESTHETIC

Model Number	BA110113
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Rn# (b)(4), complaint took place in australia.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 australia: "pt had a brachial plexus block placed during surgery on the (b)(6) 2025.The catheter was for removal on (b)(6) 2025.On removal by nursing staff the plastic separated from the metal coil and the coil remained stuck in the patients wound.The metal was then removed by the surgeons and an x-ray was performed.I have not yet heard the results of x-ray.

• Brand Name: INFILTRALONG SET 700
• Common Device Name: INFILTRALONG SET 700_CATHETER, CONDUCTION, ANESTHETIC
• 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: 21916576
• Report Number: 9611612-2025-00011
• Device Sequence Number: 21031698
• Product Code: BSO
• UDI-Device Identifier: 04048223049624
• UDI-Public: 04048223049624
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K080675
• 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): 04/28/2025

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: BA110113
• Device Catalogue Number: 001158-30C
• Device Lot Number: 1563
• 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: 04/10/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• 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