MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG SONO L75 G19; PERIPHERAL NERVE BLOCK KIT

Model Number 561187-31A

Device Problems Detachment Of Device Component (1104); Fracture (1260); Difficult to Remove (1528); Device Issue (2379); Patient-Device Incompatibility (2682); Device-Device Incompatibility (2919); Mechanical Jam (2983)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 05/26/2016

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).User's narrative: at the removal of the needle, the catheter was dissociated of his elocal coil.A 10cm of catheter got stuck in the body of the patient.The surgeon tried to take off the catheter without success.Patient received antibiotic and he remained under observation.

Manufacturer Narrative

Based on risk assessment and clinical evaluation file is considered as closed.Not returned.

Event Description

(b)(4).At the removal of the needle, the catheter was dissociated of his elocal coil.Ten cm of cathter is got stuck in the body of the patient.The surgeon tried to take off the catheter without success.Patient received antibiotic and he remained under observation.

• Brand Name: SONOLONG SONO L75 G19
• 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: 5777732
• MDR Text Key: 49783067
• Report Number: 9611612-2016-00098
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K113188
• 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: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/01/2020
• Device Model Number: 561187-31A
• Device Catalogue Number: 561187-31A
• Device Lot Number: 1118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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