MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE STIMULONG SONO TSUI; NERVE BLOCK KIT, PERIPHERAL AND EPIDURAL USE

Model Number 521156-35U

Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/18/2016

Event Type  Injury  

Manufacturer Narrative

At this time the information available is very poor.Neither the device nor the lot's have been identified clearly.User facility asked mfr to send a report to fda asap.As soon as more details will become available a follow up report will be sent in to the fda.

Event Description

(b)(4).Summary from user's narrative: sheered a tsui catheter in a pediatric patient spine.They performed a caudal block for a cancer patient.They had to perform surgery to remove the catheter (4 inch piece sheared off).

Manufacturer Narrative

At this time, the information available is still poor.Neither the device nor the lot# have been identified clearly.User facility asked mfr to send a report to fda asap.As soon as more details will become available, a follow up report will be sent in to the fda.

Event Description

Internal report-number: (b)(4).Hospital reported sonolong tsui catheter sheared and remained in patient.Patient was taken in the or for catheter retrieval.

Manufacturer Narrative

Based on risk assessment and clinical evaluation file is considered as closed.

Event Description

(b)(4).Hospital reported sonolong tsui catheter sheared and remained in patient.Patient was taken in the or for catheter retrieval.

• Brand Name: STIMULONG SONO TSUI
• Type of Device: NERVE BLOCK KIT, PERIPHERAL AND EPIDURAL USE
• 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: 5814723
• MDR Text Key: 50176699
• Report Number: 9611612-2016-00104
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/01/2018
• Device Model Number: 521156-35U
• Device Catalogue Number: 521156-35U
• Device Lot Number: 1044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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