MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOTAP; ANAESTHESIA CONDUCTION NEEDLE, PERIPHERAL, SINGLE-SHOT

Model Number	1185-3E080
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Initial reporter´s medwatch report number: (b)(4).
Event or Problem Description
(b)(4).Initial reporter´s narrative: needle is blocked prior to use.
Event or Problem Description
(b)(4).Initial reporter´s narrative: needle is blocked prior to use.
Additional Manufacturer Narrative
Based on risk assessment and clinical evaluation file is considered as closed.

• Brand Name: SONOTAP
• Common Device Name: ANAESTHESIA CONDUCTION NEEDLE, PERIPHERAL, SINGLE-SHOT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7111801
• Report Number: 9611612-2017-00020
• Device Sequence Number: 19128357
• Product Code: BSP
• UDI-Device Identifier: 14048223019761
• UDI-Public: 14048223019761
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2018

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: Physician
• Device Expiration Date: 07/31/2022
• Device Model Number: 1185-3E080
• Device Catalogue Number: 1185-3E080
• Device Lot Number: 1217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 01/30/2018
• 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