FDA Adverse Event Malfunction Summary report: N

SPLIT SEPTUM MICRO T-CONNECTOR

MDR report key: 23728332 · Received December 5, 2025

Report

Report Number
23728332
Event Type
Malfunction
Date Received
December 5, 2025
Date of Event
November 14, 2025
Report Date
November 20, 2025
Manufacturer
HUMMINGBIRD MED DEVICES INC
Product Code
FPA
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

S [SITUATION]: BLOOD AND TPN [TOTAL PARENTERAL NUTRITION] WERE DRIPPING FROM THE HUMMI DEVICE WHERE THE HARD PLASTIC MEETS THE SOFTER TUBING. B [BACKGROUND]: PT WAS IN BED AND NOTED TO HAVE FRANK BLOOD ON ITEM IN BED, RN NOTICED BED LINEN WAS WET AND SMELLED LIKE TPN. RN QUICKLY NOTICED RED LUMEN OF PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] LINE WAS BACKED UP WITH BLOOD AND BLOOD WAS LEAKING. RN TIGHTENED ALL CONNECTIONS IN ATTEMPT TO STOP THE BACKFLOW OF BLOOD. UNSUCCESSFUL SO RN CLAMPED THE LINE CLOSEST TO PATIENT TO TOP FURTHER BLOOD LOSS. RN NOTICED BLOOD/TPN FLUIDS DRIPPING FROM HUMMI TUBING. THIS HUMMI DEVICE IS THE FIRST PIECE OF EQUIPMENT THAT ATTACHES TO THE PICC LINE. THE BLOOD AND TPN WERE DRIPPING FROM THE HUMMI DEVICE WHERE THE HARD PLASTIC MEETS THE SOFTER TUBING. A [ASSESSMENT]: RN USED STERILE TECHNIQUE TO REPLACE THE CRACKED HUMMI WITH A NEW ONE. CARE TEAM DISCUSSED THE PRODUCT ISSUE WITH A KENTEC REP WHO HAS ENSURED THAT A NEW T-CONNECTOR, WHICH HAS THICKER PLASTIC, IS IN PRODUCTION, AND WITH EVERY NEW ORDER PLACED BEGINNING TODAY, WILL RECEIVE THE UPDATED T-CONNECTOR. MANY OTHER FACILITIES HAVE EXPERIENCED THE SAME ISSUE WITH HUMMI T-CONNECTORS. THE DEFECTIVE PRODUCT WILL BE SENT TO KENTEC, AS THEY PROVIDE A SHIPPING BOX. PRODUCT BEING STOCKED IN NEONATAL UNITS AT THIS TIME: 6" MINIBORE EXTENSION SET WITH SPLIT SEPTUM MICRO T-CONNECTOR, MANUFACTURER: KENTEC MEDICAL, REF #: NMT8046, LOT: 25114.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2810214 SPLIT SEPTUM MICRO T-CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA HUMMINGBIRD MED DEVICES INC NMT8046 25114 (CURRENT STOCK)

Patients

Seq Age Sex Outcome Treatment
1 5 MO Male