ULTRASAFE X100L PNG RASPBERRY NVS STEIN 47450530

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-03-09 for ULTRASAFE X100L PNG RASPBERRY NVS STEIN 47450530 manufactured by Becton Dickinson Hungary Kft (bd).

MAUDE Entry Details

• Report Number: 3009081593-2020-00025
• MDR Report Key: 9805927
• Report Source: DISTRIBUTOR,OTHER
• Date Received: 2020-03-09
• Date of Report: 2020-03-24
• Date of Event: 2020-01-10
• Date Mfgr Received: 2020-02-18
• Device Manufacturer Date: 2018-05-01
• Date Added to Maude: 2020-03-09
• 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: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: BDX BRETT WILKO
• Manufacturer Street: 9450 SOUTH STATE STREET
• Manufacturer City: SANDY UT 84070
• Manufacturer Country: US
• Manufacturer Postal: 84070
• Manufacturer Phone: 8015652341
• Manufacturer G1: BECTON DICKINSON HUNGARY KFT (BD)
• Manufacturer Street: UVEGGYAR UTCA 3
• Manufacturer City: KORNYE TATABANYA 2851
• Manufacturer Country: HU
• Manufacturer Postal Code: 2851
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ULTRASAFE X100L PNG RASPBERRY NVS STEIN
• Generic Name: PISTON SYRINGE
• Product Code: MEG
• Date Received: 2020-03-09
• Catalog Number: 47450530
• Lot Number: 8121735
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BECTON DICKINSON HUNGARY KFT (BD)
• Manufacturer Address: UVEGGYAR UTCA 3 KORNYE TATABANYA 2851 HU 2851

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-03-09