BIOFLEX TESIO CATH (LEFT) KIT BFL-6-J

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-13 for BIOFLEX TESIO CATH (LEFT) KIT BFL-6-J manufactured by Medical Components, Inc..

MAUDE Entry Details

• Report Number: 2518902-2020-00016
• MDR Report Key: 9828663
• Report Source: DISTRIBUTOR,FOREIGN
• Date Received: 2020-03-13
• Date of Report: 2020-03-30
• Date of Event: 2019-12-11
• Report Date: 2020-02-19
• Date Reported to Mfgr: 2020-02-19
• Date Mfgr Received: 2020-03-30
• Device Manufacturer Date: 2019-05-14
• Date Added to Maude: 2020-03-13
• 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: LYNN WINKLER
• Manufacturer Street: 1499 DELP DRIVE
• Manufacturer City: HARLEYSVILLE PA 19438
• Manufacturer Country: US
• Manufacturer Postal: 19438
• Manufacturer Phone: 2152564201
• Manufacturer G1: MEDICAL COMPONENTS, INC.
• Manufacturer Street: 1499 DELP DRIVE
• Manufacturer City: HARLEYSVILLE PA 19438
• Manufacturer Country: US
• Manufacturer Postal Code: 19438
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BIOFLEX TESIO CATH (LEFT) KIT
• Generic Name: BIO-FLEX TESIO
• Product Code: MSD
• Date Received: 2020-03-13
• Returned To Mfg: 2020-03-06
• Model Number: BFL-6-J
• Catalog Number: BFL-6-J
• Lot Number: MNBA950
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDICAL COMPONENTS, INC.
• Manufacturer Address: 1499 DELP DRIVE HARLEYSVILLE PA 19438 US 19438

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-13