ORTHO SUMMIT PROCESSOR 7003015 936480

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-24 for ORTHO SUMMIT PROCESSOR 7003015 936480 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[326417] While processing plates on the osp using syringe the tech observed that the syringes were bent in such a way that may cause them to improperly dispense fluid into the microwell. No death or serious injury was associated with this incident. This report corresponds to ortho-clinical diagnostics complaint number 31200588.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2250051-2003-00939
• MDR Report Key: 474563
• Date Received: 2003-07-24
• Date of Report: 2003-07-23
• Date of Event: 2003-07-16
• Date Facility Aware: 2003-07-16
• Report Date: 2003-07-23
• Date Added to Maude: 2003-07-31
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• 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
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ORTHO SUMMIT PROCESSOR
• Generic Name: SAMPLE PROCESSOR
• Product Code: GKH
• Date Received: 2003-07-24
• Model Number: 7003015
• Catalog Number: 936480
• Lot Number: 31003
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 463408
• Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
• Manufacturer Address: 1001 US HWY 202 RARITAN NJ 088690606 US
• Baseline Brand Name: ORTHO SUMMIT PROCESSOR
• Baseline Generic Name: SAMPLE PROCESSOR
• Baseline Model No: 7003015
• Baseline Catalog No: 936480
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-07-24