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

Model Number 531187-31A

Device Problems Device Or Device Fragments Location Unknown (2590); Device Handling Problem (3265)

Patient Problems Awareness during Anaesthesia (1707); Device Embedded In Tissue or Plaque (3165)

Event Date 01/14/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6) and has not been reported to national health authorities.We consider this file as closed.

Event Description

(b)(4).Summarizing translation of user's/reporters narrative: suddenly catheter broke without overburdening.

• Brand Name: SONOLONG SONO
• Type of Device: PERIPHERAL NERVE BLOCK 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; regulatory & safety affairs; geisingen, baden-wuerttemberg 78187 ; GM 78187 ; 7704929158
• MDR Report Key: 5503649
• MDR Text Key: 40408332
• Report Number: 9611612-2016-00033
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Model Number: 531187-31A
• Device Catalogue Number: 531187-31A
• Device Lot Number: 1139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention