FDA Adverse Event Malfunction Summary report: N

VERSAFLEX DISPOSABLE PH CATHETER

MDR report key: 3220892 · Received July 8, 2013

Report

Report Number
3220892
Event Type
Malfunction
Date Received
July 8, 2013
Date of Event
May 30, 2013
Report Date
June 30, 2013
Manufacturer
GIVEN IMAGING
Product Code
FFT
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI, US

Narratives

Description of Event or Problem · 1

24H PH PROBE PLACED. POST PLACEMENT CXR OBTAINED SHOWING INTACT PROBE IN ESOPHAGUS. MOTHER REPORTING PATIENT COMPLAINED OF THROAT PAIN THE EVENING OF PLACEMENT, AND THAT PATIENT PULLED PROBE OUT SHORTLY AFTER 12:30AM THE DAY IMMEDIATELY FOLLOWING PLACEMENT. NO RESTRAINTS IN PLACE. WHEN PROBE OUT, MOTHER NOTICED DISTAL TIP SEEMED SHARP. AS TECH RETRIEVED EQUIPMENT THAT MORNING, OBSERVED DISTAL TIP MISSING. PATIENT WITHOUT HEMATEMESIS OR ABDOMINAL PAIN. SERVICE INTERN AWARE OF SITUATION. FLOOR NURSING STAFF HAD ALREADY CONTACTED SERVICE FOR MD EVALUATION. READING FROM STUDY INDICATED PROBE SUCCESSFULLY RECORDING FOR APPROX. 10 HOURS BEFORE NO READING. MOTHER APPROVED INSERTION OF NEW PROBE THAT MORNING, AND INSERTION OCCURRED WITHOUT DIFFICULTY. SECOND PROBE WAS FROM SAME LOT NUMBER. REMAINING STOCK OF THAT LOT NUMBER SEQUESTERED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PH MONITORING.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
308622 VERSAFLEX DISPOSABLE PH CATHETER ELECTRODE, PH, STOMACH FFT GIVEN IMAGING * F1246304UA

Patients

Seq Age Sex Outcome Treatment
1 5 YR