MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE UNIPLEX NANOLINE; PERIPHERAL NERVE BLOCK NEEDLE

Model Number	001156-74
Medical Device Problem Codes	Fluid/Blood Leak (1250); Nonstandard Device (1420); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	Awareness during Anaesthesia (1707); No Consequences Or Impact To Patient (2199); Inadequate Pain Relief (2388)
Date of Event	09/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary pajunk medical (b)(4).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).Summarizing tentative translation from initial reporter's narrative: leakage at the hub.
Additional Manufacturer Narrative
Based on risk assessment and clinical evaluation file is considered as closed.
Event or Problem Description
(b)(4).Summarizing tentative translation from initial reporter´s narrative: leakage at the very proximal hub of the injection tube.

• Brand Name: UNIPLEX NANOLINE
• Common Device Name: PERIPHERAL NERVE BLOCK NEEDLE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 6059532
• Report Number: 9611612-2016-00142
• Device Sequence Number: 422857
• Product Code: BSP
• UDI-Device Identifier: 04048223002988
• UDI-Public: 04048223002988
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K053283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2016

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: 07/01/2017
• Device Model Number: 001156-74
• Device Catalogue Number: 001156-74
• Device Lot Number: 981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2016
• Supplement Report FDA Received Date: 12/12/2016
• 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