FDA Adverse Event Death Summary report: N

ENTRIFLEX

MDR report key: 920 · Received July 21, 1992

Report

Report Number
920
Event Type
Death
Date Received
July 21, 1992
Date of Event
July 2, 1992
Report Date
July 13, 1992
Manufacturer
BIOSEARCH MEDICAL PRODUCTS, INC.
Product Code
FPD
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

PATIENT DIAGNOSED AS ACUTE RENAL FAILURE, OBSTRUCTIVE UROPATHY, PNEUMONIA AND SEVERE CONFUSION. PATIENT HAD BEEN RECEIVING NASO-GASTRIC TUBE FEEDING BUT HAD REMOVED HIS TUBE. A NEW NASO-GASTRIC TUBE (ENTRIFLEX) WAS REINSERTED BY THE PHYSICIAN, VERIFICATION OF TUBE PLACEMENT DONE BY PHYSSSICIAN BY INJECTING AIR INTO THE TUBE AND NOTING GURGLING SOUNDS IN STOMACH, IN ADDITION A PORTABLE CHEST X-RAY WAS ORDERED TO CHECK TUBE PLACEMENT. HOWEVER, TUBE FEEDING WAS STARTED BY PRIVATE DUTY NURSE BEFORE THE CHEST X-RAY WAS DONE. THE PATIENT EXPIRED DUE TO RESPIRATORY ARREST. CHEST X-RAY REVEALED LOCATION OF NG TUBE AS IN THE RIGHT LUNG AND FLUID IN LOBESDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: INHERENT RISK OF PROCEDURE. CONCLUSION: THERE WAS NO DEVICE FAILURE, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED, OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ENTRIFLEX DUAL PORT FEEDING TUBE FPD BIOSEARCH MEDICAL PRODUCTS, INC. 9113

Patients

Seq Age Sex Outcome Treatment
1 87 YR Death