MILLIPORE SLFG025PB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-23 for MILLIPORE SLFG025PB manufactured by Millipore Corp..

Event Text Entries

[21696617] The tansducer's projectors not holding pressure. They are constantly filling up. Transfducer projector reportedly interferred with proper monitoring of venous pressure, resulting in hematoma of pt. Access.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2243621-1995-00113
• MDR Report Key: 20483
• Date Received: 1995-02-23
• Date of Report: 1995-02-02
• Date of Event: 1995-01-12
• Date Facility Aware: 1995-01-19
• Report Date: 1995-02-02
• Date Reported to FDA: 1995-02-02
• Date Reported to Mfgr: 1995-02-02
• Date Added to Maude: 1995-03-22
• 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: MILLIPORE
• Generic Name: TRANSDUCER PROJECTOR
• Product Code: FIB
• Date Received: 1995-02-23
• Catalog Number: SLFG025PB
• Lot Number: H4MM02763
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 20370
• Manufacturer: MILLIPORE CORP.
• Manufacturer Address: 80 ASHBY ROAD BEDFORD MA 01730 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1995-02-23