SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB 305269

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 2020-03-02 for SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB 305269 manufactured by Becton Dickinson Medical Systems.

MAUDE Entry Details

• Report Number: 1213809-2020-00155
• MDR Report Key: 9776830
• Report Source: DISTRIBUTOR,OTHER
• Date Received: 2020-03-02
• Date of Report: 2020-03-06
• Date of Event: 2020-01-28
• Date Mfgr Received: 2020-02-11
• Device Manufacturer Date: 2019-01-18
• Date Added to Maude: 2020-03-02
• 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: 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 MEDICAL SYSTEMS
• Manufacturer Street: ROUTE 7 AND GRACE WAY
• Manufacturer City: CANAAN CT 06018
• Manufacturer Country: US
• Manufacturer Postal Code: 06018
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB
• Generic Name: PISTON SYRINGE
• Product Code: MEG
• Date Received: 2020-03-02
• Returned To Mfg: 2020-02-24
• Model Number: 305269
• Catalog Number: 305269
• Lot Number: 9018575
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BECTON DICKINSON MEDICAL SYSTEMS
• Manufacturer Address: ROUTE 7 AND GRACE WAY CANAAN CT 06018 US 06018

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-03-02