STANDARD SPROTTE NEEDLE 321151-31A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-19 for STANDARD SPROTTE NEEDLE 321151-31A manufactured by Pajunk Gmbh Medizintechnologie.

MAUDE Entry Details

• Report Number: 9611612-2020-00003
• MDR Report Key: 9724718
• Report Source: DISTRIBUTOR
• Date Received: 2020-02-19
• Date of Report: 2020-03-09
• Date of Event: 2020-01-30
• Date Mfgr Received: 2020-01-31
• Device Manufacturer Date: 2017-10-24
• Date Added to Maude: 2020-02-19
• 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
• 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: STANDARD SPROTTE NEEDLE
• Generic Name: INTRATHECAL NEEDLE, SINGLE USE
• Product Code: BSP
• Date Received: 2020-02-19
• Model Number: 321151-31A
• Catalog Number: 321151-31A
• Lot Number: 1226
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• 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. Required No Informationntervention	2020-02-19