FDA Adverse Event Injury Summary report: N

KIM MED TECH INC.

MDR report key: 3671 · Received June 1, 1992

Report

Report Number
3671
Event Type
Injury
Date Received
June 1, 1992
Date of Event
February 14, 1992
Report Date
February 24, 1992
Manufacturer
KIM ENDOSCOPIC NASAL INTESTIONAL TUBE SET
Product Code
FEG
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

PATIENT COMBATIVE, STAFF TRYING TO RESTRAIN, TUBING (02 AND SMALL BOWEL DECOMPRESSION TUBING ) BECAME DISCONNECTED. RN BECAME CONCERNED ABOUT PATIENT CONDITION, RN QUICKLY CONNECTED TUBING AND INADVERTINGLY CONNECTED THE DECOMPRESSION (INTESTIONAL TUBE) TUBE TO THE OXYGEN SET UP. IT WAS CONNECTED FOR LESS THAN 1 MINUTE, WHEN PATIENT BECAME ABDOMINALLY DISTENDED AND COMPLAINED OF PAIN. ABDOMINAL FILMS SHOWING FREE AIR IN PERITONEUM. PATIENT TAKEN TO SURGERY FOR REPAIR OF PREEXISTING SMALL BOWEL OBSTRUCTIONDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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 NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN, INCORRECT TECHNIQUE/PROCEDURE, OTHER, TUBING. CONCLUSION: USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 KIM MED TECH INC. FEG KIM ENDOSCOPIC NASAL INTESTIONAL TUBE SET 8909G563821

Patients

Seq Age Sex Outcome Treatment
1 75 YR Required Intervention