BARD INFANT CATH KIT 0035630

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-10-01 for BARD INFANT CATH KIT 0035630 manufactured by .

MAUDE Entry Details

• Report Number: 1018233-2002-00033
• MDR Report Key: 420540
• Report Source: 06
• Date Received: 2002-10-01
• Date of Event: 2002-04-25
• Date Mfgr Received: 2002-09-19
• Date Added to Maude: 2002-10-08
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: VIVIAN STEPHENS, MANAGER
• Manufacturer Street: 8195 INDUSTRIAL BLVD
• Manufacturer City: COVINGTON GA 30014
• Manufacturer Country: US
• Manufacturer Postal: 30014
• Manufacturer Phone: 7707846902
• 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: BARD INFANT CATH KIT
• Generic Name: URINE SPECIMEN KIT
• Product Code: FFH
• Date Received: 2002-10-01
• Model Number: NA
• Catalog Number: 0035630
• ID Number: NA
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 402518
• Baseline Brand Name: BARD INFANT CATH KIT
• Baseline Generic Name: URINE SPECIMEN KIT
• Baseline Model No: NA
• Baseline Catalog No: 0035630
• Baseline ID: NA
• Baseline Device Family: INFANT, FEMALE AND PEDIATRIC CATH KITS
• Baseline Shelf Life Contained: Y
• Baseline Shelf Life [Months]: 36
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K905016
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-10-01