SHARPX NEEDLE DESTRUCTION UNIT NDU-1 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-05-22 for SHARPX NEEDLE DESTRUCTION UNIT NDU-1 * manufactured by Biomedical Disposal, Inc..

Event Text Entries

[17421662] 4/21/2000 during morning clinic set-up, nurse removed device from overnight charger to place in pt care area. When placing unit into stationary base, nurse placed finger over insertion point for needle. Reportedly, a "burned or black" metal fragment (residual from burned needle) became lodged in nurse's finger. Fragment was removed by clinic manager & discarded. Clinic manager reported incident to corporate office.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1065528-2000-00001
• MDR Report Key: 280574
• Report Source: 05,06
• Date Received: 2000-05-22
• Date of Report: 2000-05-19
• Date of Event: 2000-04-21
• Date Facility Aware: 2000-04-21
• Report Date: 2000-05-19
• Date Reported to Mfgr: 2000-04-21
• Date Mfgr Received: 2000-04-21
• Device Manufacturer Date: 1999-04-01
• Date Added to Maude: 2000-06-07
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: DEIDRE WILLIAMS
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Manufacturer Phone: 3009595
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SHARPX NEEDLE DESTRUCTION UNIT
• Generic Name: NEEDLE DESTRUCTION UNIT
• Product Code: MTV
• Date Received: 2000-05-22
• Returned To Mfg: 2000-04-24
• Model Number: NDU-1
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 1 YR
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 271530
• Manufacturer: BIOMEDICAL DISPOSAL, INC.
• Manufacturer Address: 3690 HOLCOMB BRIDGE RD NORCROSS GA 300922257 US
• Baseline Brand Name: SHARPX NEEDLE DESTRUCTION UNIT
• Baseline Generic Name: NEEDLE DESTRUCTION UNIT
• Baseline Model No: NDU-1
• Baseline Catalog No: NA
• Baseline Device Family: NDU
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: Y
• Premarket Approval: P9800
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2000-05-22