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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-31 for * manufactured by Argon Medical Devices Inc..

Event Text Entries

[3331861] Staff member reports several manifold kits have been found broken prior to use. Leaking saline was noticed and/or bleed back in the sheath from the pressure line. Then staff began assessing them before use and found cracks. Initially only one lot number was involved and it was removed from use. Today a second lot number was noted to be broken again at a luer attachment by manufacturer. What was the original intended procedure? Device to be used for cardiac catheter to obtian pressures, obtain specimens and administer fluids. Device #1is this a laboratory device or laboratory test? Nodevice #2is this a laboratory device or laboratory test? No
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2957100
• MDR Report Key: 2957100
• Date Received: 2012-12-31
• Date of Report: 2012-12-31
• Date of Event: 2012-12-19
• Report Date: 2012-12-31
• Date Reported to FDA: 2012-12-31
• Date Reported to Mfgr: 2013-02-12
• Date Added to Maude: 2013-02-12
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• 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 Sequence Number: 1

• Brand Name: *
• Generic Name: ADAPTOR, STOPCOCK, MANIFOLD
• Product Code: OJA
• Date Received: 2012-12-31
• Model Number: *
• Catalog Number: *
• Lot Number: 11026454
• ID Number: *
• Device Availability: Y
• Device Age: 1 DY
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ARGON MEDICAL DEVICES INC.
• Manufacturer Address: 1445 FLAT CREEK RD. ATHENS TX 75751 US 75751

Device Sequence Number: 2

• Brand Name: *
• Generic Name: ADAPTOR, STOPCOCK, MANIFOLD
• Product Code: DTL
• Date Received: 2012-12-31
• Model Number: *
• Catalog Number: *
• Lot Number: 11028628
• ID Number: *
• Device Availability: Y
• Device Age: 1 DY
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ARGON MEDICAL DEVICES INC.
• Manufacturer Address: 1445 FLAT CREEK RD. ATHENS, TX 75751 TX 75751 US 75751

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-12-31