MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG SONO; CONTINUOUS PERIPHERAL ANAESTHESIA CONDUCTING KIT

Model Number 531187-31A

Device Problems Fracture (1260); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(6) - pajunk medical produkte (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 translation and summary of initial reporter's narrative: rupture - fragment remains with patient.

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary (b)(4).2 lot were reported: 1216 = (b)(6) 2017 (mfr.).1222 = (b)(6) 2017 (mfr.) based on risk assessment and clinical evaluation file is considered as closed.

Event Description

Irn# (b)(4).Tentative translation and summary of initial reporter narrative: rupture - fragment remains with patient.

• Brand Name: SONOLONG SONO
• Type of Device: CONTINUOUS PERIPHERAL ANAESTHESIA CONDUCTING 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; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7098937
• MDR Text Key: 94192670
• Report Number: 9611612-2017-00016
• Device Sequence Number: 1
• Product Code: CAZ
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

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?: No
• Device Operator: Physician
• Device Expiration Date: 07/24/2022
• Device Model Number: 531187-31A
• Device Catalogue Number: 531187-31A
• Device Lot Number: 1216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 11/10/2017
• Supplement Dates FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2017
• 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): Required Intervention