SPROTTE NRFIT 121163-30A 121166-30A KIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-02 for SPROTTE NRFIT 121163-30A 121166-30A KIT manufactured by Pajunk Gmbh Medizintechnologie.

MAUDE Entry Details

• Report Number: 9611612-2019-00022
• MDR Report Key: 9143778
• Date Received: 2019-10-02
• Date of Report: 2019-10-08
• Date of Event: 2019-07-29
• Date Mfgr Received: 2019-09-07
• Device Manufacturer Date: 2017-07-04
• Date Added to Maude: 2019-10-02
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR CHRISTIAN QUASS
• Manufacturer Street: KARL-HALL-STR. 1 TUTTLINGER STR. 7
• Manufacturer City: GEISINGEN, 78187
• Manufacturer Country: GM
• Manufacturer Postal: 78187
• Manufacturer G1: PAJUNK GMBH MEDIZINTECHNOLOGIE
• Manufacturer Street: KARL-HALL-STR. 1 TUTTLINGER STR. 7
• Manufacturer City: GEISINGEN, 78187
• Manufacturer Country: GM
• Manufacturer Postal Code: 78187
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SPROTTE NRFIT
• Generic Name: NEEDLE, ANAESTHESIA CONDUCTION, SINGLE SHOT
• Product Code: BSP
• Date Received: 2019-10-02
• Returned To Mfg: 2019-08-23
• Model Number: 121163-30A
• Catalog Number: 121166-30A KIT
• Lot Number: 1213
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PAJUNK GMBH MEDIZINTECHNOLOGIE
• Manufacturer Address: KARL-HALL-STR. 1 TUTTLINGER STR. 7 GEISINGEN, 78187 GM 78187

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-10-02