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

Model Number 001187-77

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

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

Currently the data is poor and the device has not been returned/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.

Event Description

(b)(4).Aspiration of air leakage of anesthetics lot 1251, lot 1252, lot 1220.

Manufacturer Narrative

Based on risk assessment and clinical evaluation this case is considered as closed.- attachment: [complaint report for 292-18.Pdf].

Event Description

Irn# 579_292-18.Aspiration of air leakage of anesthetics.Lot 1251, lot 1252, lot 1220.

• Brand Name: SONOPLEX
• Type of Device: PERIPHERAL NERVE BLOCK NEEDLE DUAL GUIDANCE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7808168
• MDR Text Key: 118252944
• Report Number: 9611612-2018-00036
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223020606
• UDI-Public: 14048223020606
• Combination Product (y/n): N
• PMA/PMN Number: K111374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

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: Health Professional
• Device Expiration Date: 09/11/2022
• Device Model Number: 001187-77
• Device Catalogue Number: 001187-77
• Device Lot Number: 1220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 08/23/2018
• Supplement Dates Manufacturer Received: 08/20/2018
• Supplement Dates FDA Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other