HEMOSPLIT CATHETER UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2003-08-20 for HEMOSPLIT CATHETER UNK manufactured by Bard Access Systems.

Event Text Entries

[16360671] They had difficult flow and think there is a crack in the line.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1720496-2003-00134
• MDR Report Key: 480181
• Report Source: 07
• Date Received: 2003-08-20
• Date of Report: 2003-08-11
• Report Date: 2003-08-11
• Date Reported to Mfgr: 2003-08-11
• Date Mfgr Received: 2003-08-11
• Date Added to Maude: 2003-08-28
• 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: MR NITIN PATIL, MGR
• Manufacturer Street: 5425 WEST AMELIA EARHART DR
• Manufacturer City: SALT LAKE CITY UT 84116
• Manufacturer Country: US
• Manufacturer Postal: 84116
• Manufacturer Phone: 8015950700
• 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: HEMOSPLIT CATHETER
• Generic Name: IMPLANTED BLOOD ACCESS DEVICE
• Product Code: FJT
• Date Received: 2003-08-20
• Returned To Mfg: 2003-08-12
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: UNKNOWN
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: I
• Device Sequence No: 1
• Device Event Key: 469028
• Manufacturer: BARD ACCESS SYSTEMS
• Manufacturer Address: 5425 WEST AMELIA EARHART DR. SALT LAKE CITY UT 84116 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2003-08-20