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

Model Number 531185-31A

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913); Device Handling Problem (3265)

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

Event Date 08/12/2016

Event Type  Injury  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary (b)(4), the user and (b)(6).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 translation from user's narrative: upon stimulating the coated needle using a braun hns nerve stimulator the needle failed, no impulse was applied.Happened 4 times using the same stimulator by 3 different anaesthesia physicians; 3 needles have been discarded, only 1 device available for investigation; can be picked up along with unused needles from the same lot for analysis after holiday.

Manufacturer Narrative

As soon as further significant data will be available, a follow up report will be sent in to the agency.Based on risk assessment and clinical evaluation, file is considered as closed.

Event Description

(b)(4).Summarizing translation from user's narrative: upon stimulating the coated needle using a bbraun hns nerve stimulator, the needle failed, no impulse was applied.Happened 4 times using the same stimulator by 3 different anaesthesia physicians; 3 needles have been discarded, only 1 device available for investigation; can be picked up along with unused needles from the same lot for analysis after holiday.

• Brand Name: SONOLONG ECHO
• 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: 5895859
• MDR Text Key: 53673510
• Report Number: 9611612-2016-00111
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/09/2016

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: 05/01/2021
• Device Model Number: 531185-31A
• Device Catalogue Number: 531185-31A
• Device Lot Number: 1161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 08/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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