MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE RECTUS SHEATH BLOCK KIT; PERIPHERAL NERVE BLOCK KIT

Model Number 0721153-49

Device Problems Break (1069); Device Handling Problem (3265)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 11/09/2016

Event Type  Injury  

Manufacturer Narrative

Currently the data is poor (neither lot nor details are known) 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 narrative from initial reporter: the catheter was surgical inserted and when removed the last 1.5 cms sheared off and was left in the patient.

Manufacturer Narrative

Currently, the data is poor (neither lot nor details are known) 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.Device not returned.

Event Description

(b)(4).Summarizing narrative from initial reporter: the catheter was surgical inserted and when removed the last 1.5cms sheared off and was left in the patient.

• Brand Name: RECTUS SHEATH BLOCK KIT
• 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: 6150240
• MDR Text Key: 61596366
• Report Number: 9611612-2016-00151
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K082164
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 0721153-49
• Device Catalogue Number: 0721153-49
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention