BALLARD MINI-BAL SAMPLING CATHETER 143 101111901

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2019-09-11 for BALLARD MINI-BAL SAMPLING CATHETER 143 101111901 manufactured by Avanos Medical Inc..

MAUDE Entry Details

• Report Number: 8030647-2019-00087
• MDR Report Key: 8989074
• Report Source: DISTRIBUTOR,USER FACILITY
• Date Received: 2019-09-11
• Date of Report: 2019-09-11
• Date of Event: 2019-08-22
• Date Mfgr Received: 2019-08-29
• Date Added to Maude: 2019-09-11
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• 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 84160
• Manufacturer Country: MX
• Manufacturer Postal Code: 84160
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BALLARD MINI-BAL SAMPLING CATHETER
• Generic Name: VAP AIRWAY DIAGNOSTICS BAL-CATH
• Product Code: OYI
• Date Received: 2019-09-11
• Model Number: 143
• Catalog Number: 101111901
• Lot Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• 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	1. Required No Informationntervention	2019-09-11