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

Model Number	001156-30G
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in (b)(6) and has been reported through (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: needle is not tight between steel and plastic hub, 2 needles involved.
Additional Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary (b)(4).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: needle is not tight between steel and plastic hub, 2 needles involved.

• Brand Name: UNIPLEX
• 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: 5979262
• Report Number: 9611612-2016-00133
• Device Sequence Number: 11002447
• Product Code: BSP
• UDI-Device Identifier: 04048223002896
• UDI-Public: 04048223002896
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/07/2017

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: 08/01/2019
• Device Model Number: 001156-30G
• Device Catalogue Number: 001156-30G
• Device Lot Number: 1078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2016
• Supplement Report FDA Received Date: 03/07/2017
• 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