MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE - NRFIT; ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE-SHOT

Model Number 121166-30A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

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).Initial reporter´s narrative: defect in spinal needle distal to hub, injecting fluid leaked out from defect outside the skin.Unable to give accurate amount of la drug down spinal.

Manufacturer Narrative

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

Event Description

(b)(4).Initial reporter´s narrative: defect in spinal needle distal to hub, injecting fluid leaked out from defect outside the skin.Unable to give accurate amount of la drug down spinal.

• Brand Name: SPROTTE - NRFIT
• Type of Device: ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE-SHOT
• 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: 7111802
• MDR Text Key: 95764389
• Report Number: 9611612-2017-00021
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K160294
• 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: 01/18/2018

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 Expiration Date: 07/03/2022
• Device Model Number: 121166-30A
• Device Catalogue Number: 001163-30A
• Device Lot Number: 1213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 12/12/2017
• Supplement Dates FDA Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2017
• 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): Other