MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE STIMULONG NANOLINE; CONTINUOUS PERIPHERAL ANAESTHESIA CONDUCTING KIT

Model Number NOT AVAILABLE

Device Problems Fracture (1260); Material Integrity Problem (2978); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/08/2017

Event Type  Injury  

Manufacturer Narrative

Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available, a follow up report will be sent in to the agency.

Event Description

(b)(4).Initial reporter´s narrative: stimulation wire came out of catheter tube.

Manufacturer Narrative

Item number and manufacturing lot can neither be identified nor reconstructed.Based on risk assessment and clinical evaluation file is considered as closed.

Event Description

Irn# (b)(4).Initial reporter´s narrative: stimulation wire came out of catheter tube.

• Brand Name: STIMULONG NANOLINE
• Type of Device: CONTINUOUS PERIPHERAL ANAESTHESIA CONDUCTING KIT
• 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: 7098952
• MDR Text Key: 94192444
• Report Number: 9611612-2017-00017
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: NOT AVAILABLE
• Device Catalogue Number: NOT REPORTET
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention