PARKER
Report
- Report Number
- 3000219639-2025-00027
- Event Type
- Death
- Date Received
- March 5, 2025
- Date of Event
- January 28, 2025
- Report Date
- May 22, 2025
- Manufacturer
- PARKER MEDICAL
- Product Code
- BTR
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 05 MARCH 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.
THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 05 MARCH 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY. COMPLAINT WAS CONSIDERED CONFIRMED BASED ON CUSTOMER NARRATIVE OF EVENTS. A 24 MONTH REVIEW WAS CONDUCTED AND 0 ADDITIONAL COMPLAINTS WERE IDENTIFIED RELATED TO THIS ISSUE. NO TREND WAS OBSERVED. THE LOT NUMBER WAS NOT PROVIDED, AND THE VENDOR WAS NOTIFIED OF THE INCIDENT. THIS INCIDENT WAS NOT IDENTIFIED AS AN INCREASING TREND. NO FURTHER ACTION TO BE TAKEN.
IT WAS REPORTED THAT THE CUFF WAS MISALIGNED TOWARD THE TIP, EXPOSING THE AIRFLOW HOLE IN THE INFLATING LINE, WHICH IS NORMALLY LOCATED INSIDE THE CUFF, AND THAT AN AIR LEAK HAD OCCURRED AT THIS POINT. A PATIENT (80-YEAR-OLD MALE) WHO WAS INTUBATED WITH THIS PRODUCT ON JANUARY 14 DEVELOPED VOICE LEAKAGE (AIR LEAK) IMMEDIATELY AFTER POSITIONAL CHANGE ON JANUARY 19, AND SINCE THE LEAKAGE DID NOT IMPROVE EVEN AFTER AIR WAS SUPPLIED TO THE CUFF, THE TUBE WAS REPLACED. WHEN AIR WAS SUPPLIED TO THE PRODUCT AFTER EXTUBATION, IT WAS CONFIRMED THAT AIR COULD NO LONGER ENTER THE CUFF. THE PATIENT SUBSEQUENTLY DIED. HOWEVER, ACCORDING TO THE HOSPITAL, THERE WAS NO DIRECT CAUSAL RELATIONSHIP BETWEEN THE LEAK AND THE DEATH.
IT WAS REPORTED THAT THE CUFF WAS MISALIGNED TOWARD THE TIP, EXPOSING THE AIRFLOW HOLE IN THE INFLATING LINE, WHICH IS NORMALLY LOCATED INSIDE THE CUFF, AND THAT AN AIR LEAK HAD OCCURRED AT THIS POINT. A PATIENT (80-YEAR-OLD MALE) WHO WAS INTUBATED WITH THIS PRODUCT ON JANUARY 14 DEVELOPED VOICE LEAKAGE (AIR LEAK) IMMEDIATELY AFTER POSITIONAL CHANGE ON JANUARY 19, AND SINCE THE LEAKAGE DID NOT IMPROVE EVEN AFTER AIR WAS SUPPLIED TO THE CUFF, THE TUBE WAS REPLACED. WHEN AIR WAS SUPPLIED TO THE PRODUCT AFTER EXTUBATION, IT WAS CONFIRMED THAT AIR COULD NO LONGER ENTER THE CUFF. THE PATIENT SUBSEQUENTLY DIED. HOWEVER, ACCORDING TO THE HOSPITAL, THERE WAS NO DIRECT CAUSAL RELATIONSHIP BETWEEN THE LEAK AND THE DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 374896 | PARKER | ENDOTRACHEAL TUBE, SUB-GLOTTIC SUCTION, PARKER FLEX-TIP, HV / LP POLYURETHANE CU | BTR | PARKER MEDICAL | I-PFTVPU-80 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Male | Death |