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

Model Number 521187-31B

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2017

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(b)(4).From initial reporter´s narrative: 521187-31b sonolong sono upon removal of the catheter, the metal coil was withdrawn proximally from the catheter.Catheter was used as intended without inner coil.

• 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: 6652843
• MDR Text Key: 77914754
• Report Number: 9611612-2017-00005
• 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: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/01/2021
• Device Model Number: 521187-31B
• Device Catalogue Number: 521187-31B
• Device Lot Number: 1163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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): Other