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); 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 07/26/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(4) 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 partially blocked.

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 partially blocked.

• 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: 5828442
• MDR Text Key: 51385441
• Report Number: 9611612-2016-00108
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/01/2021
• Device Model Number: 1185-3E080
• Device Catalogue Number: 1185-3E080
• Device Lot Number: 1148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/28/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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