400ML TRANSFER BAG WITH PIERCING PIN T3104

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-27 for 400ML TRANSFER BAG WITH PIERCING PIN T3104 manufactured by Charter Medical, Ltd..

MAUDE Entry Details

• Report Number: 1066733-2020-00005
• MDR Report Key: 9635090
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2020-01-27
• Date of Report: 2020-01-27
• Date of Event: 2019-12-16
• Date Mfgr Received: 2019-12-16
• Device Manufacturer Date: 2019-08-13
• Date Added to Maude: 2020-01-27
• 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 HINSHAW
• Manufacturer Street: 3948-A WESTPOINT BLVD.
• Manufacturer City: WINSTON SALEM NC 271036770
• Manufacturer Country: US
• Manufacturer Postal: 271036770
• Manufacturer Phone: 3367686447
• Manufacturer G1: CHARTER MEDICAL, LTD.
• Manufacturer Street: 3948-A WESTPOINT BLVD.
• Manufacturer City: WINSTON SALEM NC 271036770
• Manufacturer Country: US
• Manufacturer Postal Code: 271036770
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 400ML TRANSFER BAG WITH PIERCING PIN
• Generic Name: 400ML TRANSFER BAG WITH PIERCING PIN
• Product Code: KSR
• Date Received: 2020-01-27
• Returned To Mfg: 2020-01-06
• Model Number: T3104
• Catalog Number: T3104
• Lot Number: 157358
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CHARTER MEDICAL, LTD.
• Manufacturer Address: 3948-A WESTPOINT BLVD. WINSTON SALEM NC 271036770 US 271036770

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-27