MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG SONO; PERIPHERAL NERVE BLOCK KIT

Model Number 521187-31C

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/12/2017

Event Type  Injury  

Manufacturer Narrative

We got aware of this reported event through regular maude database research on february 10th 2017.Tried to identify initial reporter/ user facility through distributor listed in report ((b)(4)).Unable to exactly identify user facility.February 28th we received fda´s notice with further details (user facility´s report number mw5067820) but still are unable to identify user facility.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.Based on risk assessment and clinical evaluation, file is considered as closed if no further information becomes available.Device not returned.

Event Description

(b)(4).From database and report submitted by fda: used pajunk sonolong kit for adductor continuous block.Difficult to thread catheter.Attempted to remove catheter through needle and 2cm catheter sheared off and was retained in the patient´s thigh.No intervention needed unless patient develops subsequent problems.While pulling the catheter back into the needle, to readjust its position.The tip of the catheter broke off into the patient (a 2 cm piece).The physician and the surgeon discussed the risks and benefits of operating the site to find and remove the catheter versus leaving it in.The decision was to leave it in.

Manufacturer Narrative

This follow up is filed due to an error in the initial report.There has been a mixup of complaint numbers assigned.This follow up corrects the fals and misleading information contained in the initial report.The actual device has been evaluated and the final evaluation report is part of this submission of a follow up report.February 28th we received fda´s notice with further details (user facility's report number mw5067820) but still are unable to identify user facility.Based on risk assessment and clinical evaluation, file is considered as closed if no further information becomes available.

Event Description

(b)(4).From database and report submitted by fda: used pajunk sonolong kit for adductor continuous block.Difficult to thread catheter.Attempted to remove catheter through needle and 2cm catheter sheared off and was retained in the patient´s thigh.No intervention needed unless patient develops subsequent problems.While pulling the catheter back into the needle, to readjust its position.The tip of the catheter broke off into the patient (a 2 cm piece).The physician and the surgeon discussed the risks and benefits of operating the site to find and remove the catheter versus leaving it in.The decision was to leave it in.

• Brand Name: SONOLONG SONO
• Type of Device: PERIPHERAL NERVE BLOCK KIT
• 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: 6363422
• MDR Text Key: 68465071
• Report Number: 9611612-2017-00003
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/01/2020
• Device Model Number: 521187-31C
• Device Catalogue Number: 521187-31C
• Device Lot Number: 1137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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