MAUDE Adverse Event Report: HUMMINGBIRD MED SPLIT SEPTUM MICRO T-CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number NMT8046

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 08/06/2020

Event Type  malfunction  

Event Description

Rn noted that hummi 6" minibore extension set with split tubing cracked close to 1.5-2cm away from hummi hub, noted to have small amount of blood leaking due to blood backing up.Nnp (neonatal nurse practitioner) aware.

• Brand Name: SPLIT SEPTUM MICRO T-CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): HUMMINGBIRD MED; 1283 elger bay road ste d; camano island WA 98282
• MDR Report Key: 10459646
• MDR Text Key: 204546610
• Report Number: 10459646
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NMT8046
• Device Lot Number: 1923
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 90 DA