CVP MANOMETER MX441B

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2003-04-16 for CVP MANOMETER MX441B manufactured by Medex.

Event Text Entries

[332446] The stopcocks are snapping off. No further information available.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1526863-2003-00046
• MDR Report Key: 454368
• Report Source: 00
• Date Received: 2003-04-16
• Date of Report: 2003-03-20
• Date Mfgr Received: 2003-03-20
• Device Manufacturer Date: 2001-02-01
• Date Added to Maude: 2003-04-21
• 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: 0
• Manufacturer Contact: TERRI DAVIS
• Manufacturer Street: 6250 SHIER-RINGS ROAD
• Manufacturer City: DUBLIN OH 43016
• Manufacturer Country: US
• Manufacturer Postal: 43016
• Manufacturer Phone: 6147915542
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CVP MANOMETER
• Generic Name: MANOMETER SETS
• Product Code: KRK
• Date Received: 2003-04-16
• Model Number: NA
• Catalog Number: MX441B
• Lot Number: 31B120110
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 443370
• Manufacturer: MEDEX
• Manufacturer Address: 6250 SHIER-RINGS ROAD DUBLIN OH 43016 US
• Baseline Brand Name: CVP MANOMETER
• Baseline Generic Name: MANOMETER SETS
• Baseline Model No: NA
• Baseline Catalog No: MX441B
• Baseline ID: NA
• Baseline Device Family: MANOMETER SETS
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K904674
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-04-16