FDA Adverse Event Malfunction Summary report: N

SPLIT SEPTUM MICRO T-CONNECTOR

MDR report key: 13117512 · Received December 30, 2021

Report

Report Number
13117512
Event Type
Malfunction
Date Received
December 30, 2021
Date of Event
December 17, 2021
Report Date
December 27, 2021
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

AFTER CHANGE OF SHIFT, COLLECTION OF FLUID & BLOOD FOUND UNDER BABY¿S HEAD AND SHOULDERS. PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE RED LUMEN FOUND TO BE LEAKING BACK THROUGH THE T-CONNECTOR, WHERE THE RUBBER STOPPER USUALLY IS, WHICH WAS NOW MISSING. MOST LIKELY DISLODGED DURING A BLOOD DRAW. PATIENT HAS A 2.6FR DL (DOUBLE LUMEN) PICC IN UPPER RIGHT EXTREMITY. RED LUMEN IS USED FOR LAB DRAWS THROUGH THE RUBBER STOPPER ON THE T-CONNECTOR. LINE WAS ACCESSED FOR A LAB DRAW EARLIER THAT MORNING AT 416 PER CHART BY NIGHT NURSE. BLOOD NOTICED AT 0732 BY DAY NURSE AFTER REPORT. ENOUGH BLOOD AND FLUID TO SOAK THROUGH Z-FLO COVER AROUND BOTH SIDES OF THE HEAD AND ONTO BLANKETS THROUGH TO THE BOTTOM BLANKET. CLOTS FOUND IN HAIR. EBL (ESTIMATED BLOOD LOSS) 10-15ML. RUBBER STOPPER FOUND ON COVER NEAR HEAD. INFANT REMAINED STABLE PER VS (VITAL SIGNS) AND ASSESSMENT. T-CONNECTOR REPLACED, AND PROVIDER NOTIFIED IMMEDIATELY. FAULTY T-CONNECTOR SAVED AND WILL BE GIVEN TO APCM (ASSISTANT PATIENT CARE MANAGER). PROVIDER TEAM TO DECIDE IF NECESSARY TO OBTAIN ADDITIONAL LAB WORK AND/OR TRANSFUSE INFANT. THERE WAS NO HARM IN THIS EVENT. THIS IS NOT A RECURRING ISSUE. EVENT HAS BEEN LOGGED FOR TRACKING PURPOSES. SUPPLY CHAIN WILL CONTINUE TO MONITOR ISSUES RELATED TO THIS ITEM. THERE HAS NOT BEEN AN OFFICIAL RECALL FOR THE ITEM FROM THE MANUFACTURER. INFORMATION ON THE DEFECT WILL BE FORWARDED ON TO THE MANUFACTURER TO FILE A QUALITY REPORT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2017535 SPLIT SEPTUM MICRO T-CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA HUMMINGBIRD MED DEVICES INC NMT8046 21210

Patients

Seq Age Sex Outcome Treatment
1 90 DA Male