MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG ECHO TUOHY L50 G18; ANAESTHESIA CONDUCTION CATHETER, PERIPHERAL, CONTINUOUS ADMINISTRATION

Model Number	531185-31C
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(6).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 or Problem Description
(b)(4).Initial reporters narrative:an extremity of the kt around 13 cm is stayed in the back of the patient during the punction.This punction was done without difficulty.The kt has been implemented to realize a surgery.He has been impossible to inject at the end of the surgery.It was notice that a bend of the kt was present at the initial punction.To try to remove this kt bend, this one is broken.After ultrasound scan check, it was impossible to find the kt.The hospital decided to let the kt and the patient has been informed.An attempts to localize the kt by scan will be done in the future.

• Brand Name: SONOLONG ECHO TUOHY L50 G18
• Common Device Name: ANAESTHESIA CONDUCTION CATHETER, PERIPHERAL, CONTINUOUS ADMINISTRATION
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 8454706
• Report Number: 9611612-2019-00008
• Device Sequence Number: 429708
• Product Code: BSO
• UDI-Device Identifier: 14048223019716
• UDI-Public: 14048223019716
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/27/2019

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: 02/01/2021
• Device Model Number: 531185-31C
• Device Catalogue Number: 531185-31C
• Device Lot Number: 1151
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 03/27/2019
• 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