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

Model Number 001185-71

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Connection Problem (2900)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6) is the information available is very poor.In case further information becomes available, a follow up will be sent.Not returned.

Event Description

(b)(4).Event took place in (b)(6) and has been reported by (b)(4) distributor: users narrative: leakage at the cable connection.

Manufacturer Narrative

Event took place in (b)(6).This individual case is considered as closed.Device not returned.

Event Description

(b)(4).Users narrative: leakage at the cable connection.

• Brand Name: SONOPLEX
• 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: 5446614
• MDR Text Key: 39079431
• Report Number: 9611612-2016-00008
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/01/2020
• Device Model Number: 001185-71
• Device Catalogue Number: 001185-71
• Device Lot Number: 1118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 02/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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