0.5ML 31GX6MM U-100 INSULIN SYRINGE 328520

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 2020-03-19 for 0.5ML 31GX6MM U-100 INSULIN SYRINGE 328520 manufactured by Bd Medical - Diabetes Care.

MAUDE Entry Details

• Report Number: 1920898-2020-00281
• MDR Report Key: 9857377
• Report Source: DISTRIBUTOR,OTHER
• Date Received: 2020-03-19
• Date of Report: 2020-03-27
• Date of Event: 2020-02-27
• Date Mfgr Received: 2020-02-28
• Device Manufacturer Date: 2019-08-27
• Date Added to Maude: 2020-03-19
• 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
• 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: BD MEDICAL - DIABETES CARE
• Manufacturer Street: 1329 WEST HIGHWAY 6
• Manufacturer City: HOLDREGE NE 68949
• Manufacturer Country: US
• Manufacturer Postal Code: 68949
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 0.5ML 31GX6MM U-100 INSULIN SYRINGE
• Generic Name: PISTON SYRINGE
• Product Code: FMF
• Date Received: 2020-03-19
• Model Number: 328520
• Catalog Number: 328520
• Lot Number: 9203946
• 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: BD MEDICAL - DIABETES CARE
• Manufacturer Address: 1329 WEST HIGHWAY 6 HOLDREGE NE 68949 US 68949

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-03-19