FDA Adverse Event Injury Summary report: N

Q CARE Q4 DEGREE ORAL CLEANSING & SUCTIONING SYSTEM

MDR report key: 1221994 · Received November 6, 2008

Report

Report Number
1419181-2008-00018
Event Type
Injury
Date Received
November 6, 2008
Date of Event
October 17, 2008
Report Date
October 17, 2008
Manufacturer
SAGE PRODUCTS, INC.
Product Code
JOL
PMA / PMN Number
K901806
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

REPORT REC'D OF A USER ERROR RESULTING IN A SUCTION SWAB DISENGAGEMENT. REPORTER STATED IN 2008 AT 4:30 AM, A NURSE ATTEMPTED TO PROVIDE ORAL CARE TO A PT WHO HAD RECENTLY BEEN EXTUBATED. REPORTER STATED THAT THE INVOLVED PT WAS VERY UNCOOPERATIVE AND COULD NOT FOLLOW COMMANDS AS HE DID NOT SPEAK ENGLISH. ALTHOUGH THE PT DID NOT HAVE TEETH, WHEN THE NURSE PLACED A SUCTION SWAB INSIDE THE PT'S MOUTH, HE BIT DOWN ON IT. THE NURSE THEN BENT THE SUCTION SWAB BACK AND FOURTH SEVERAL TIMES IN ATTEMPT TO FREE THE SUCTION SWAB. REPORTEDLY, THE PLASTIC STRAW SEPARATED INTO TWO PIECES. X-RAYS WERE PERFORMED IN AN ATTEMPT TO ASCERTAIN THE LOCATION OF THE SWAB HEAD; HOWEVER, IT COULD NOT BE VISUALIZED. REPORTER STATED THAT UPON VISUAL INSPECTION, THE SWAB HEAD WITH ATTACHED PIECE OF PLASTIC HANDLE WAS NOTED IN THE PT'S UPPER PHARYNX, ABOVE THE PT'S VOCAL CORDS. THE PT'S SURGEON UNSUCCESSFULLY ATTEMPTED TO REMOVE THE FOAM HEAD WITH ATTACHED PIECE OF PLASTIC USING FORCEPS. THE REPORTER STATED THAT ALTHOUGH THE PT SHOWED NO SIGNS OF RESPIRATORY DISTRESS, THE PT'S SURGEON DECIDED TO REINTUBATE THE PT. A PULMONOLOGIST PREFORMED A BRONCHOSCOPY AND WAS THEN ABLE TO REMOVE THE SWAB HEAD WITH ATTACHED PIECE OF PLASTIC HANDLE. THE REPORTER STATED THAT THE PULMONOLOGIST EXAMINED THE UPPER PHARYNX AND DETERMINED THAT THERE WERE NO SCRATCHES OR BLEEDING NOTED. THE PT WAS EXTUBATED ON TWO DAYS LATER. INSTRUCTIONS FOR USE STATE, "A BITE BLOCK SHOULD BE USED WHEN PERFORMING ORAL CARE ON PTS WITH ALTERED LEVELS OF CONSCIOUSNESS OR THOSE WHO CANNOT COMPREHEND COMMANDS." REPORTER STATED THAT ALTHOUGH THE PT WAS UNCOOPERATIVE AND UNABLE TO FOLLOW COMMANDS, A BITE BLOCK WAS NOT USED AT THE TIME OF THE INCIDENT. REPORTER STATED THE INVOLVED SUCTION SWAB WAS SAVED; HOWEVER, DECLINED TO RETURN TO SAGE PRODUCTS, INC. FOR EVAL. LOT INFO WAS NOT AVAILABLE FROM RPTR. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 Q CARE Q4 DEGREE ORAL CLEANSING & SUCTIONING SYSTEM SUCTION SWAB JOL SAGE PRODUCTS, INC. 6404 UNK

Patients

Seq Age Sex Outcome Treatment
1 UNK Required Intervention