MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE STIMULONG SONO TSUI; ANAESTHESIA CONDUCTION KIT

Model Number	531156-35U
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently the device has not been returned for investigation.Based on risk assessment and clinical monitoring the event seems to be a known complication of the procedure.As soon as further information becomes available, mfr will send an updated report to the agency.
Event or Problem Description
Irn# (b)(4).Dr.Was having difficulty feeding the catheter once it reached the end of the touchy needle and decided to abort the procedure and pulled the catheter out.When catheter was removed he noticed the gold tip of the catheter did not return and was dislodged inside the patient.He described that he could not retrieve it with the touchy needle and was consulting with the surgeon on how to remove.Dr.(b)(6) is off for a couple days and planning on meeting with him next week to gain more details.He had to send the product to path/risk and he is not aware as to how they will release it to us for investigation but we will cover with them in our meeting next week.Another procedure was done to remove the piece left behind and they were successful in removing it.(doctor) did not disclose if there were any complications.

• Brand Name: STIMULONG SONO TSUI
• Common Device Name: ANAESTHESIA CONDUCTION KIT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 13511667
• Report Number: 9611612-2022-00003
• Device Sequence Number: 6514522
• Product Code: CAZ
• UDI-Device Identifier: 04048223117262
• UDI-Public: 04048223117262
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K062900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/11/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2025
• Device Model Number: 531156-35U
• Device Catalogue Number: 531156-35U
• Device Lot Number: 1340
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2020
• 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: Required Intervention
• Patient Sex: Unknown