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

Model Number 001156-70

Device Problem Blocked Connection (2888)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6).As soon as the investigations are finished a follow up report will be sent in.

Event Description

(b)(4).Tentative summarizing translation from user's narrative: upon injection the needle was blocked.

Manufacturer Narrative

This was an individual case resulting from inappropriate manufacturing control in an individual case.This file is considered as closed.

Event Description

(b)(4).Tentative summarizing translation from user's narrative: upon injection the needle was blocked, 4 needles involved.

• 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: 5549693
• MDR Text Key: 41940211
• Report Number: 9611612-2016-00042
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K053283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/01/2019
• Device Model Number: 001156-70
• Device Catalogue Number: 001156-70
• Device Lot Number: 1113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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