FDA Adverse Event Death Summary report: N

ENTRIFLEX FEEDING TUBE

MDR report key: 50696 · Received November 22, 1996

Report

Report Number: 2242547-1996-00005
Event Type: Death
Date Received: November 22, 1996
Date of Event: October 24, 1996
Manufacturer: BIOSEARCH MEDICAL PRODUCTS, INC
Product Code: KNT
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

REFERENCE MFR. COMPLAINT #V96-10-25-231. PT WAS AN ELDERLY FEMALE WITH THROAT ANOMALIES RESULTING FROM PREVIOUS SURGERIES. PLACEMENT OF THE FEEDING TUBE WAS DIFFICULT DUE TO CONDITION OF PT'S THROAT. RN PLACING TUBE CAUSED PNEUMOTHORAX. FAMILY REFUSED ADDITIONAL INTERVENTION OF BEHALF OF THE PT AND SHE EXPIRED. EVALUATION OF THE RETURNED USED DEVICE REVEALED IMPROPER USER TECHNIQUE PER PACKAGE LABELING. PT'S PREEXISTING CONDITIONS FIT PROFILE OF HIGH RISK PT. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OF THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED. UF# 39C00001-1996-6.

Description of Event or Problem · 1

CUSTOMER REPORTED PT DIED, 10/24/1996. NURSING REPORTEDLY "ATTEMPTED TO INSERT ENTERIFLEX FEEDING TUBE. SEVERAL ATTEMPTS WERE MADE. RESISTANCE MET-CHECKED END TUBE IN WATER, WHEN BUBBLED-REMOVED IMMEDIATELY. ATTEMPTS TERMINATED AT 10:20 AM. PHYSICIANS NOTIFIED. AT 11:00 AM PT EXPERIENCED RESPIRATORY DISTRESS. CODE CALLED, PT INTUBATED. CHEST TUBE PLACED. TRANSFERRED TO CRITICAL CARE. PT DIED OF TENSION PNEUMOTHORAX, RESPIRATORY ARREST."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENTRIFLEX FEEDING TUBE	FEEDING TUBE	KNT	BIOSEARCH MEDICAL PRODUCTS, INC	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR		Death