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

Model Number 001185-71

Device Problems Device Operates Differently Than Expected (2913); Device Handling Problem (3265)

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

Event Date 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(4).Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.

Event Description

(b)(4).Initial reporters narrative: needle did not work with braun hns12, performance was confirmed with multistim.

Manufacturer Narrative

Based on risk assessment and clinical evaluation file is considered as closed.

Event Description

(b)(4).Initial reporters narrative: needle did not work with bbraun hns12, performance was confirmed with multistim.

• 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: 5905933
• MDR Text Key: 54154109
• Report Number: 9611612-2016-00120
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/01/2021
• Device Model Number: 001185-71
• Device Catalogue Number: 001185-71
• Device Lot Number: 1148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2016
• Initial Date FDA Received: 08/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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