MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; ANAESTHESIA CONDUCTION NEEDLE, SPINAL

Model Number 121151-30A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Awareness during Anaesthesia (1707); Inadequate Pain Relief (2388)

Event Date 08/13/2017

Event Type  malfunction  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through distribution subsidiary (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).Summary from initial reporter´s narrative: spinal needle leakage.

Manufacturer Narrative

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

Event Description

(b)(4).Summary from initial reporter´s narrative: spinal needle leakage.

• Brand Name: SPROTTE
• Type of Device: ANAESTHESIA CONDUCTION NEEDLE, SPINAL
• 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: 7111791
• MDR Text Key: 94631548
• Report Number: 9611612-2017-00019
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

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?: Yes
• Device Operator: Physician
• Device Model Number: 121151-30A
• Device Catalogue Number: 121151-30A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 12/06/2017
• Supplement Dates FDA Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: 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