ADULT ET CLOSED SUCTION CATHETER
Report
- Report Number
- 3006061749-2025-00059
- Event Type
- Malfunction
- Date Received
- October 21, 2025
- Date of Event
- October 17, 2025
- Report Date
- March 13, 2026
- Manufacturer
- FLEXICARE MEDICAL LTD
- Product Code
- BSY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 501
Narratives
AWAITING COMPLETION OF INVESTIGATION BEFORE ANY CONCLUSIONS CAN BE MADE IN TERMS OF THE INCIDENT ROOT CAUSE.
AWAITING COMPLETION OF INVESTIGATION BEFORE ANY CONCLUSIONS CAN BE MADE IN TERMS OF THE INCIDENT ROOT CAUSE.
AWAITING COMPLETION OF INVESTIGATION BEFORE ANY CONCLUSIONS CAN BE MADE IN TERMS OF THE INCIDENT ROOT CAUSE. THE COMPLAINT COULD NOT BE CONFIRMED AS NO LOT NUMBER, PHOTO, VIDEO, OR PHYSICAL SAMPLE WAS PROVIDED, PREVENTING ANY DEVICE-SPECIFIC INVESTIGATION OR DHR REVIEW. A REVIEW OF COMPLAINT DATA FROM (B)(6) 2024 TO (B)(6) 2025 IDENTIFIED NO PREVIOUS REPORTS OF THIS FAILURE MODE, INDICATING THIS IS THE FIRST KNOWN OCCURRENCE AND REMAINS WITHIN THE ACCEPTABLE RISK CRITERIA. BASED SOLELY ON THE USER DESCRIPTION, THE MOST PROBABLE CAUSE IS ASSUMED TO RELATE TO CATHETER DESIGN CHARACTERISTICS COMBINED WITH LIMITED USER FAMILIARITY WITH THE INSERTION TECHNIQUE; HOWEVER, THIS CANNOT BE VERIFIED DUE TO THE ABSENCE OF OBJECTIVE EVIDENCE. WITH NO ABILITY TO REPRODUCE THE ISSUE AND NO TREND OF SIMILAR COMPLAINTS, NO FURTHER ACTION IS REQUIRED AT THIS TIME, AND THE CASE WILL CONTINUE TO BE MONITORED THROUGH ROUTINE PMS TRENDING. THIS IS THE FINAL REPORT FOR (B)(4).
"THE CONCERNS INCLUDE DECREASED SUCTION CAPABILITY, RESISTANCE WHEN ADVANCING THE CATHETER, BUNCHING OF THE CATHETER COVER, AND INABILITY TO ADCANCE CATHETER. THE END USER STATES THAT THE NEW CLICS ARE DIFFICULT TO ADVANCE THROUGH THE ENDOTRACHEAL (ET) TUBE. THEY CANNOT BE FULLY INSERTED, WHICH SIGNIFICANTLY IMPACTS SUCTION DEPTH AND MAKES THE PROCESS TIME CONSUMING. IN EMERGENCIES, THIS DELAY CAN HINDER THE RAPID REMOVAL OF SECTRTIONS, POTENTIALLY COMPRIMISING PATIENT CARE. THE NEW BALLARDS REMAIN HARD TO ADVCANCE THROUGH THE ENDOTRACHAEL (ET) TUBE LIMITING FULL INSERTION AND REDUCING THE ELLECTIVENESS OF SUCTIONING. THIS CONTINUES TO BE TIME CONSUMING AND PROBLOMATIC, ESPECIALLY IN EMERGENCY SITUATIONS WHERE QUICK REMOVAL OF SECRETIONS IS CRITICSL." NO REPORT OF SERIOUS INJURY / HARM TO PATIENT OR USER. NO INDIRECT HARMJ REPORTED. NO REPORT OF REQUIRMENT TO INTERVIEN TO PREVENT PERMANENT DAMAGE. NO REPORT OF HOSPITALISATION - INITAL OR STAY PROLONGED BY 1 DAY OR MORE. NO REPORT OF SERIOUS INJURY, DISABILITY OR PERMANENT IMPAIRMENT. NOT REPORTED AS LIFE THREATENING. NO DEATH REPORTED.
"THE CONCERNS INCLUDE DECREASED SUCTION CAPABILITY, RESISTANCE WHEN ADVANCING THE CATHETER, BUNCHING OF THE CATHETER COVER, AND INABILITY TO ADVANCE CATHETER. THE END USER STATES THAT THE NEW CLICKS ARE DIFFICULT TO ADVANCE THROUGH THE ENDOTRACHEAL (ET) TUBE. THEY CANNOT BE FULLY INSERTED, WHICH SIGNIFICANTLY IMPACTS SUCTION DEPTH AND MAKES THE PROCESS TIME CONSUMING. IN EMERGENCIES, THIS DELAY CAN HINDER THE RAPID REMOVAL OF SECRETIONS, POTENTIALLY COMPROMISING PATIENT CARE. THE NEW BALLARDS REMAIN HARD TO ADVANCE THROUGH THE ENDOTRACHEAL (ET) TUBE LIMITING FULL INSERTION AND REDUCING THE ELECTIVENESS OF SUCTIONING. THIS CONTINUES TO BE TIME CONSUMING AND PROBLEMATIC, ESPECIALLY IN EMERGENCY SITUATIONS WHERE QUICK REMOVAL OF SECRETIONS IS CRITICAL.". NO REPORT OF SERIOUS INJURY / HARM TO PATIENT OR USER. NO INDIRECT HARM REPORTED. NO REPORT OF REQUIREMENT TO INTERVENE TO PREVENT PERMANENT DAMAGE. NO REPORT OF HOSPITALISATION - INITIAL OR STAY PROLONGED BY 1 DAY OR MORE. NO REPORT OF SERIOUS INJURY, DISABILITY OR PERMANENT IMPAIRMENT. NOT REPORTED AS LIFE THREATENING. NO DEATH REPORTED.
"THE CONCERNS INCLUDE DECREASED SUCTION CAPABILITY, RESISTANCE WHEN ADVANCING THE CATHETER, BUNCHING OF THE CATHETER COVER, AND INABILITY TO ADVANCE CATHETER." THE END USER STATES THAT THE NEW CLICS ARE DIFFICULT TO ADVANCE THROUGH THE ENDOTRACHEAL (ET) TUBE. THEY CANNOT BE FULLY INSERTED, WHICH SIGNIFICANTLY IMPACTS SUCTION DEPTH AND MAKES THE PROCESS TIME CONSUMING. IN EMERGENCIES, THIS DELAY CAN HINDER THE RAPID REMOVAL OF SECRETIONS, POTENTIALLY COMPROMISING PATIENT CARE. THE NEW BALLARDS REMAIN HARD TO ADVANCE THROUGH THE ET TUBE LIMITING FULL INSERTION AND REDUCING THE EFFECTIVENESS OF SUCTIONING. THIS CONTINUES TO BE TIME CONSUMING AND PROBLEMATIC, ESPECIALLY IN EMERGENCY SITUATIONS WHERE QUICK REMOVAL OF SECRETIONS IS CRITICAL. NO REPORT OF SERIOUS INJURY/HARM TO PATIENT OR USER. NO REPORT OF INDIRECT HARM. NO REPORT OF REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE. NO REPORT OF HOSPITALISATION - INITIAL OR STAY PROLONGED BY 1 DAY OR MORE. NO REPORT OF SERIOUS INJURY, DISABILITY OR PERMANENT IMPAIRMENT. NOT REPORTED AS LIFE-THREATENING. NO REPORT OF DEATH.
"THE CONCERNS INCLUDE DECREASED SUCTION CAPABILITY, RESISTANCE WHEN ADVANCING THE CATHETER, BUNCHING OF THE CATHETER COVER, AND INABILITY TO ADCANCE CATHETER. THE END USER STATES THAT THE NEW CLICS ARE DIFFICULT TO ADVANCE THROUGH THE ENDOTRACHEAL (ET) TUBE. THEY CANNOT BE FULLY INSERTED, WHICH SIGNIFICANTLY IMPACTS SUCTION DEPTH AND MAKES THE PROCESS TIME CONSUMING. IN EMERGENCIES, THIS DELAY CAN HINDER THE RAPID REMOVAL OF SECRETIONS, POTENTIALLY COMPROMISING PATIENT CARE. THE NEW BALLARDS REMAIN HARD TO ADVANCE THROUGH THE ET TUBE LIMITING FULL INSERTION AND REDUCING THE EFFECTIVENESS OF SUCTIONING. THIS CONTINUES TO BE TIME CONSUMING AND PROBLEMATIC, ESPECIALLY IN EMERGENCY SITUATIONS WHERE QUICK REMOVAL OF SECRETIONS IS CRITICAL. NO REPORT OF SERIOUS INJURY/HARM TO PATIENT OR USER NO REPORT OF INDIRECT HARM, NO REPORT OF REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE, NO REPORT OF HOSPITALISATION - INITIAL OR STAY PROLONGED BY 1 DAY OR MORE, NO REPORT OF SERIOUS INJURY, DISABILITY OR PERMANENT IMPAIRMENT, NOT REPORTED AS LIFE-THREATENING, NO REPORT OF DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370317 | ADULT ET CLOSED SUCTION CATHETER | CATHETER | BSY | FLEXICARE MEDICAL LTD | 050-64-114U | NOT AVAILABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |