MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE E-CATH ACC. TSUI; PERIPHERAL NERVE BLOCK KIT

Model Number	251285-40E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in the u.S., and has been reported through u.S.Distributor distribution subsidiary pajunk medical systems.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).Initial reporters narrative, "missing piece on the nerve block catheter allowing the external catheter to slide on the needle resulting in shearing of the catheter.Original intended procedure: not known ;user problem: device failed (e.G.Broke, couldn't get it to work or stopped working)." initial reporter´s report number: (b)(4).
Event or Problem Description
(b)(4).Initial reporters narrative:"missing piece on the nerve block catheter allowing the external catheter to slide on the needle resulting in shearing of the catheter.Original intended procedure: not known ;user problem: device failed (e.G.Broke, couldn't get it to work or stopped working)." initial reporter´s report number: (b)(4).
Additional Manufacturer Narrative
Event took place in the us and has been reported through us distributor distribution subsidiary pajunk medical systems.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.Neither a breakdown product nor pictures of the breakdown product were sent in for investigation.The manufacturing documentation and the manufacturing specifications of the batch concerned were examined and did not allow any unfavourable conclusions to be drawn.The facts of the case were examined.Result: the error could not be reconstructed.A retention sample of the article from the batch concerned could unfortunately not be examined.We are currently not aware of any other complaints with a similar error description.A missing component of the catheter cannot be confirmed without further examination of the failure product.On the basis of the available data, a product error cannot be confirmed.Based on risk management and clinical evaluation this file is considered as closed unless further information becomes available.

• Brand Name: E-CATH ACC. TSUI
• Common Device Name: PERIPHERAL NERVE BLOCK KIT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 10668316
• Report Number: 9611612-2020-00013
• Device Sequence Number: 2728242
• Product Code: BSO
• UDI-Device Identifier: 14048223037345
• UDI-Public: 14048223037345
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K152952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other,user facili
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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: 10/21/2024
• Device Model Number: 251285-40E
• Device Catalogue Number: 251285-40E
• Device Lot Number: 1322
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 12/08/2020
• 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; Required Intervention