MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. SET, BLOOD TRANSFUSION

Lot Number 158817

Device Problems Defective Component (2292); Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2019

Event Type  malfunction  

Event Description

Neonatal / pediatric transfer set was found to be defective.Attempted to use four sets to transfuse blood with no success.The cap that is connected to the y piece would not come off.Unable to attach the med tubing device to administer blood.

• Brand Name: SET, BLOOD TRANSFUSION
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): CHARTER MEDICAL, LTD.
• MDR Report Key: 9480337
• MDR Text Key: 171810890
• Report Number: MW5091700
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/13/2019
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/10/2023
• Device Lot Number: 158817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13 DA