MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOBLOCK; PERIPHERAL NERVE BLOCK NEEDLE

Model Number 001180-81

Device Problems Nonstandard Device (1420); Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975); No Flow (2991)

Patient Problems Awareness during Anaesthesia (1707); No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6).The data available is poor.The device has not yet been returned to manufacturer.As soon as further information becomes available a follow up report will be sent in.Not yet returned.

Event Description

(b)(4).Summarizing translation from user report: needle was blocked.

Manufacturer Narrative

Based on risk assessment and clinical evaluation file is considered as closed.As soon as further significant data will be available a follow up report will be sent in to the agency.We consider this file as closed.

Event Description

(b)(4).Summarizing translation from user report: needle was blocked.

• Brand Name: SONOBLOCK
• Type of Device: PERIPHERAL NERVE BLOCK NEEDLE
• 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: 5462620
• MDR Text Key: 39085939
• Report Number: 9611612-2016-00024
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2018
• Device Model Number: 001180-81
• Device Catalogue Number: 001180-81
• Device Lot Number: 1138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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