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

Model Number 531187-32A

Device Problems Kinked (1339); Nonstandard Device (1420); Device Issue (2379); Device-Device Incompatibility (2919); Mechanical Jam (2983)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6).At this time information on the device and the incident is poor.No information about the device´s whereabout.Follow up will be sent as soon as more information becomes available.

Event Description

(b)(4).Users narrative tentative translation: catheter does not go smoothly through needle, kinks.

Manufacturer Narrative

Event took place in (b)(6).Isolated manufacturing error.If no further information becomes available, file is considered as closed.

Event Description

(b)(4).Summarizing translation from user's narrative: catheter did not pass needle smoothly, kinks.

• Brand Name: STIMULONG 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: 5446686
• MDR Text Key: 39099765
• Report Number: 9611612-2016-00018
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113188
• 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: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/01/2020
• Device Model Number: 531187-32A
• Device Catalogue Number: 531187-32A
• Device Lot Number: 1110, 1126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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