MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE STIMULONG NANOLINE; CONTINUOUS PERIPHERAL NERVE BLOCK KIT

Model Number 531156-32C

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

(b)(4).Dr.(b)(6) was performing a left infraclavicular catheter placement.According to the doctor, they could not get any stimulation.He said he usually only inserts the catheter a few centimeters past the tip of the needle.When they could not get a stimulation, the needle and catheter were pulled out together.This is when he said the catheter sheered and left a piece in the patient.The procedure was completed with a 2nd kit and broken piece was surgically removed 7 days later.Hospital would not release catheter being held in pathology but i was able to examine it and take pictures.The amount of catheter left in the patient (close to 7 cm) is inconsistent with the doctor's description of the procedure.When dr.(b)(6) was unable to stimulate, rather than remove the catheter and needle together, the tuohy needle should have been removed first, leaving the catheter in place.At that time the catheter could then be removed safely.There is nothing i observed on the catheter or 50 mm tuohy needle that indicated any flaws that could have contributed to the sheering of the catheter.Per the information at (b)(6) pathology lab: date of procedure: (b)(6) 2017.Date of removal of catheter piece: (b)(6) 2017 (b)(4).Catheter pieces reviewed and pictures taken on (b)(6) 2017.

Manufacturer Narrative

User facilities report number: (b)(4).Based on risk assessment and clinical evaluation file is considered as closed.

Event Description

(b)(4).Initial reporters narrative: dr.(b)(6) was performing a left infraclavicular catheter placement.According to the doctor, they could not get any stimulation.He said he usually only inserts the catheter a few centimeters past the tip of the needle.When they could not get a stimulation, the needle and catheter were pulled out together.This is when he said the catheter sheered and left a piece in the patient.The procedure was completed with a 2nd kit and broken piece was surgically removed 7 days later.Hospital would not release catheter being held in pathology but i was able to examine it and take pictures.The amount of catheter left in the patient (close to 7cm) is inconsistent with the doctor's description of the procedure.When dr.(b)(6) was unable to stimulate, rather than remove the catheter and needle together, the tuohy needle should have been removed first, leaving the catheter in place.At that time the catheter could then be removed safely.There is nothing i observed on the catheter or 50mm tuohy needle that indicated any flaws that could have contributed to the sheering of the catheter.Per the information at (b)(6) pathology lab: date of procedure: (b)(6) 2017.Date of removal of catheter piece: (b)(6) 2017.(b)(6).Catheter pieces reviewed and pictures taken on (b)(6) 2017.

• Brand Name: STIMULONG NANOLINE
• Type of Device: CONTINUOUS PERIPHERAL NERVE BLOCK KIT
• 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, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7002740
• MDR Text Key: 91066775
• Report Number: 9611612-2017-00010
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 11/24/2017

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
• Device Operator: Physician
• Device Expiration Date: 11/01/2020
• Device Model Number: 531156-32C
• Device Catalogue Number: 531156-32C
• Device Lot Number: 1137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 10/24/2017
• Supplement Dates FDA Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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
• Patient Age: 10 YR
• Patient Weight: 41