FDA Adverse Event Malfunction Summary report: N

ENTRIFLEX FEEDING TUBE WITH FLOW THROUGH STYLET

MDR report key: 7322 · Received December 23, 1993

Report

Report Number: 7322
Event Type: Malfunction
Date Received: December 23, 1993
Date of Event: December 10, 1993
Report Date: December 23, 1993
Manufacturer: BIOSEARCH MEDICAL PRODUCTS, INC.
Product Code: FPD
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

RN NOTED ORANGE TINTED ORAL SECRETIONS AND QUESTIONED FEEDING TUBE PLACEMENT. CHEST X-RAY ORDERED TO DETERMINE POSITION OF THE FEEDING TUBE. X-RAY SHOWED FEEDING TUBE IN THE ESOPHAGUS WITH THE WEIGHTED END BROKEN OFF AND LCOATED IN THE CECUM.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENTRIFLEX FEEDING TUBE WITH FLOW THROUGH STYLET		FPD	BIOSEARCH MEDICAL PRODUCTS, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR		Other