FDA Adverse Event Malfunction Summary report: N

B & B MEDICAL

MDR report key: 1614222 · Received February 15, 2010

Report

Report Number
1614222
Event Type
Malfunction
Date Received
February 15, 2010
Date of Event
February 4, 2010
Report Date
February 15, 2010
Manufacturer
B & B MEDICAL TECHNOLOGIES, INC./INTEGRA BIOTECHNICAL, LLC
Product Code
JXL
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CO, US

Narratives

Description of Event or Problem · 1

MALE BURN PATIENT WAS VERY RESTLESS AND AGITATED AFTER DEBRIDEMENT SURGERY. THE PATIENT WAS TRYING TO PULL OUT THE ENDOTRACHEAL TUBE. THE PATIENT WAS BITING THE TUBE AGGRESSIVELY SO THE RT AND THE RN ATTEMPTED TO PLACE A UNIVERSAL BITE BLOCK. THE BITE BLOCK HAS A ZIP TIE END WHICH IS ATTACHED TO THE BLOCK. THE END OF THE ZIP TIE HAS A PLASTIC BLUE CAP (POSSIBLY TO KEEP IT FROM POKING THROUGH THE PACKAGING). THE PLASTIC BLUE CAP FELL OFF THE TIP AND LANDED IN THE PATIENT'S MOUTH. THE RT AND THE RN ATTEMPTED TO RETRIEVE IT BUT IT DISAPPEARED. IT IS PRESUMED THE PATIENT SWALLOWED IT. THE STAFF WILL MONITOR THE PATIENT'S BOWEL MOVEMENTS IN THE MEANTIME. A XRAY WAS OBTAINED. UNFORTUNATELY, THE CAP IS NOT RADIOPAQUE, SO IT COULD NOT BE FOUND ON X-RAY. ALTHOUGH THE PATIENT IS NOW EXTUBATED AND BREATHING WELL, ASPIRATION CANNOT BE COMPLETELY RULED OUT. HOWEVER, IT IS NOT BELIEVED THAT THE PATIENT ASPIRATED THIS CAP. THE PATIENT STILL HAD THE ET TUBE CUFF INFLATED SO IT WOULD HAVE BEEN DIFFICULT FOR THE CAP TO PASS THE CUFF. THE SURROUNDING AREAS WERE SEARCHED AND THE CAP WAS NOT LOCATED. THE PACKAGING DOES NOT HAVE ANY INDICATION LISTED ABOUT REMOVING CAP BEFORE USE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 B & B MEDICAL ADULT UNIVERSAL BITE BLOCK JXL B & B MEDICAL TECHNOLOGIES, INC./INTEGRA BIOTECHNICAL, LLC ADULT #11160 051107

Patients

Seq Age Sex Outcome Treatment
1 30 YR