FDA Adverse Event Injury Summary report: N

Q CARE Q2 DEGREE ORAL CLEANSING & SUCTIONING SYSTEM

MDR report key: 1866944 · Received October 11, 2010

Report

Report Number
1419181-2010-00002
Event Type
Injury
Date Received
October 11, 2010
Date of Event
September 27, 2010
Report Date
October 11, 2010
Manufacturer
SAGE PRODUCTS, INC.
Product Code
EIA
PMA / PMN Number
K901806
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TN, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

REPORT RECEIVED OF A USER ERROR RESULTING IN A SUCTION SWAB DISENGAGEMENT. REPORTER STATED THAT ON (B)(6)2010, A NURSE ATTEMPTED TO PROVIDE ORAL CARE TO AN UNCOOPERATIVE PATIENT. WHEN THE NURSE PLACED THE SUCTION SWAB INTO THE PATIENT'S MOUTH, HE BIT DOWN ON THE SUCTION SWAB HANDLE. REPORTEDLY, THE PLASTIC STRAW SEPARATED INTO TWO PIECES. REPORTER STATED THE PATIENT INHALED THE SWAB HEAD WITH ATTACHED PIECE OF PLASTIC HANDLE. REPORTEDLY, A BRONCHOSCOPY WAS PERFORMED AND THE SWAB HEAD WITH ATTACHED PIECE OF PLASTIC HANDLE WAS REMOVED FROM THE PATIENT'S AIRWAY. IT WAS REPORTED THAT THE PATIENT DID NOT SUSTAIN INJURY FROM THE OCCURRENCE. INSTRUCTIONS FOR USE STATE, "A BITE BLOCK SHOULD BE USED WHEN PERFORMING ORAL CARE ON PATIENTS WITH ALTERED LEVELS OF CONSCIOUSNESS OR THOSE WHO CANNOT COMPREHEND COMMANDS." IT WAS REPORTED THAT ALTHOUGH THE PATIENT WAS UNCOOPERATIVE, A BITE BLOCK WAS NOT USED AT THE TIME OF THE INCIDENT. REPORTEDLY, THE SWAB HEAD WITH ATTACHED PIECE OF PLASTIC HANDLE WAS DISCARDED. THE REMAINING PLASTIC STRAW WAS SAVED, HOWEVER, FACILITY DECLINED TO RETURN IT TO SAGE PRODUCTS, INC FOR EVALUATION. LOT INFORMATION WAS NOT AVAILABLE FROM REPORTER. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 Q CARE Q2 DEGREE ORAL CLEANSING & SUCTIONING SYSTEM SUCTION SWAB EIA SAGE PRODUCTS, INC. 6602 UNK

Patients

Seq Age Sex Outcome Treatment
1 UNK Required Intervention