MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG; PERIPHERAL NERVE BLOCK CATHETER KIT

Model Number 531187-31B

Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 05/18/2017

Event Type  Injury  

Manufacturer Narrative

Based on risk assessment and clinical evaluation file is considered as closed.

Event Description

(b)(4).From initial reporter´s narrative: 531187-31b sonolong sono 53118731bb sonolong nanoline punktionskanüle upon removal of the catheter, the metal coil was withdrawn distally from the catheter and remained in the patient.Small incision had to be made to remove fragment immediately.

• Brand Name: SONOLONG
• Type of Device: PERIPHERAL NERVE BLOCK CATHETER 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, 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• MDR Report Key: 6633055
• MDR Text Key: 77286249
• Report Number: 9611612-2017-00004
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K113188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 11/21/2021
• Device Model Number: 531187-31B
• Device Catalogue Number: 531187-31B
• Device Lot Number: 1182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2016
• 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): Required Intervention