BALLARD CLOSED SUCTION CATHETER, ELBOW, NEONATAL/PEDIATRIC 20083 109243102

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-07 for BALLARD CLOSED SUCTION CATHETER, ELBOW, NEONATAL/PEDIATRIC 20083 109243102 manufactured by Avanos Medical Inc..

MAUDE Entry Details

• Report Number: 8030647-2019-00093
• MDR Report Key: 9164954
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-10-07
• Date of Report: 2019-11-27
• Date Mfgr Received: 2019-11-21
• Device Manufacturer Date: 2019-07-01
• Date Added to Maude: 2019-10-07
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. LISA CLARK
• Manufacturer Street: 5405 WINDWARD PARKWAY
• Manufacturer City: ALPHARETTA GA 30004
• Manufacturer Country: US
• Manufacturer Postal: 30004
• Manufacturer Phone: 4704485444
• Manufacturer G1: AVENT S DE RL DE CV
• Manufacturer Street: CARRETERA INTERNACIONAL SALIDA NORTE NO. 1053
• Manufacturer City: MAGDALENA, CP
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BALLARD CLOSED SUCTION CATHETER, ELBOW, NEONATAL/PEDIATRIC
• Generic Name: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Product Code: BSY
• Date Received: 2019-10-07
• Returned To Mfg: 2019-10-11
• Model Number: 20083
• Catalog Number: 109243102
• Lot Number: M19182T401
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AVANOS MEDICAL INC.
• Manufacturer Address: 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-10-07