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

Model Number 001156-74

Device Problems Fluid/Blood Leak (1250); Nonstandard Device (1420); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Awareness during Anaesthesia (1707); No Consequences Or Impact To Patient (2199); Inadequate Pain Relief (2388)

Event Date 09/15/2016

Event Type  malfunction  

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 Description

(b)(4).Summarizing tentative translation from initial reporter's narrative: leakage at the hub.

Manufacturer Narrative

Based on risk assessment and clinical evaluation file is considered as closed.

Event 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
• Type of Device: PERIPHERAL NERVE BLOCK NEEDLE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; regulatory & safety affairs; geisingen, baden-wuerttemberg 78187 ; GM 78187 ; 7704929158
• MDR Report Key: 6059532
• MDR Text Key: 58458021
• Report Number: 9611612-2016-00142
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 04048223002988
• UDI-Public: 04048223002988
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K053283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other