CADD EXTENSION SETS SET, EXTENSION, 30", M/M, 1.1 ML, ASV 50/BX 21-7045-24

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-11-15 for CADD EXTENSION SETS SET, EXTENSION, 30", M/M, 1.1 ML, ASV 50/BX 21-7045-24 manufactured by Smiths Medical Asd,inc..

MAUDE Entry Details

• Report Number: 3012307300-2019-06238
• MDR Report Key: 9331635
• Report Source: DISTRIBUTOR,HEALTH PROFESSION
• Date Received: 2019-11-15
• Date of Report: 2019-11-15
• Date of Event: 2019-10-15
• Date Mfgr Received: 2017-10-17
• Device Manufacturer Date: 2017-05-06
• Date Added to Maude: 2019-11-15
• 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: DAVE HALVERSON
• Manufacturer Street: 6000 LANE N
• Manufacturer City: MINNEAPOLIS MN 55442
• Manufacturer Country: US
• Manufacturer Postal: 55442
• Manufacturer Phone: 7633833310
• Manufacturer G1: SMITHS MEDICAL ASD,INC
• Manufacturer Street: 6000 LANE N
• Manufacturer City: MINNEAPOLIS MN 55442
• Manufacturer Country: US
• Manufacturer Postal Code: 55442
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CADD EXTENSION SETS
• Generic Name: ACCESSORIES, PUMP, INFUSION
• Product Code: MRZ
• Date Received: 2019-11-15
• Model Number: SET, EXTENSION, 30", M/M, 1.1 ML, ASV 50/BX
• Catalog Number: 21-7045-24
• Lot Number: 57X184
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SMITHS MEDICAL ASD,INC.
• Manufacturer Address: 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-11-15