FDA Adverse Event Injury Summary report: N

COOK PNEUMOTHORAX TRAY

MDR report key: 23221409 · Received October 6, 2025

Report

Report Number
MW5176916
Event Type
Injury
Date Received
October 6, 2025
Date of Event
September 6, 2025
Report Date
September 30, 2025
Manufacturer
COOK MEDICAL LLC.
Product Code
JOL
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
RISK MANAGER
Health Professional
Yes

Narratives

Description of Event or Problem · 0

THIS IS A 67-YEAR-OLD MALE WITH A PAST MEDICAL HISTORY OF COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) INITIALLY PRESENTED TO THE ED WITH WORSENING SHORTNESS OF BREATH. IMAGING NOTED LARGE RIGHT PNEUMOTHORAX. HE UNDERWENT CHEST TUBE PLACEMENT IN THE ED. PULMONARY WAS CONSULTED FOR FURTHER EVALUATION. A PHYSICIAN WAS CALLED EMERGENTLY TO BEDSIDE BY THE HOSPITALIST TEAM AS THE PATIENT WAS COMPLAINING OF SHORTNESS OF BREATH, NECK SWELLING, DIFFICULTY WITH BREATHING, AND NOTED TO HAVE EXTENSIVE SUBCUTANEOUS EMPHYSEMA AROUND THE NECK. AN RRT (REGISTERED RESPIRATORY THERAPIST) HAD BEEN CALLED DUE TO RESPIRATORY DISTRESS. HE WAS STARTED ON A NON-REBREATHER MASK WITH SOME RELIEF; A REPEAT CHEST X-RAY WAS OBTAINED WHICH SHOWED NO SIGNIFICANT INTERVAL CHANGE. ON ASSESSMENT, THERE WAS STILL SOME AIR-LEAK IN THE CHEST TUBE, HOWEVER, THE CHEST TUBE STYLETTE APPEAR TO STILL BE IN PLACE, IT WAS REMOVED AND REATTACHED THE CHEST TUBE TO THE PLEUR-EVAC WITH INCREASED AIR LEAK, THE PATIENT STATED THAT HE WAS STARTING TO FEEL BETTER. STAT CT OF THE CHEST WAS THEN OBTAINED, IT SHOWED THE RIGHT PLEURAL PIGTAIL CATHETER IN PLACE, WITH A SMALL RIGHT APICAL PNEUMOTHORAX, EXTENSIVE ASSOCIATED PNEUMOMEDIASTINUM AND SUBCUTANEOUS EMPHYSEMA IN THE BASE OF THE NECK AND CHEST WALL. IN REVIEW OF THE DEVICES, THE STRAIGHTENER WAS LEFT IN THE PIGTAIL CATHETER AND ALLOWED CONNECTION TO THE SUCTION DUE TO ITS CONFIGURATION IF THE STRAIGHTENER WAS REDESIGNED THAT MAKES THE CONNECTION UNACCEPTABLE THIS WOULD DECREASE THE LIKELIHOOD OF ERROR. WE HAVE REACHED OUT TO THE MANUFACTURE TO DISCUSS POTENTIAL REDESIGN, IF POSSIBLE. LARGE RIGHT PNEUMOTHORAX.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2226572 COOK PNEUMOTHORAX TRAY CATHETER AND TIP, SUCTION JOL COOK MEDICAL LLC. G56537

Patients

Seq Age Sex Outcome Treatment
1 67 YR Male Required Intervention