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

Model Number 1185-3E080

Device Problems Partial Blockage (1065); Nonstandard Device (1420); Product Quality Problem (1506); Physical Resistance (2578); Manufacturing, Packaging or Shipping Problem (2975); No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2016

Event Type  malfunction  

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 Description

(b)(4).Tentative summarizing translation from user's narrative: inner lumen seems to be blocked, high resistance upon injection.

Manufacturer Narrative

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

Event Description

(b)(4).Tentative summarizing translation from user´s narrative: inner lumen seems to be blocked, high resistance upon injection.

• Brand Name: SONOTAP
• 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: 5804501
• MDR Text Key: 50730210
• Report Number: 9611612-2016-00101
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K113207
• 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: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/01/2021
• Device Model Number: 1185-3E080
• Device Catalogue Number: 1185-3E080
• Device Lot Number: 1157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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