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

Model Number	001187-77
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
(b)(4).Aspiration of air leakage of anesthetics lot 1251, lot 1252, lot 1220.
Additional Manufacturer Narrative
Based on risk assessment and clinical evaluation this case is considered as closed.- attachment: [complaint report for 292-18.Pdf].
Event or Problem Description
Irn# 579_292-18.Aspiration of air leakage of anesthetics.Lot 1251, lot 1252, lot 1220.

• Brand Name: SONOPLEX
• Common Device Name: 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
• Report Number: 9611612-2018-00036
• Device Sequence Number: 1835639
• Product Code: BSP
• UDI-Device Identifier: 14048223020606
• UDI-Public: 14048223020606
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other