FDA Adverse Event Malfunction Summary report: N

EXTENDED CARE SUCTION SWAB KIT WITH BIOTENE (DENTIP ORAL SWAB)

MDR report key: 7112368 · Received December 13, 2017

Report

Report Number
7112368
Event Type
Malfunction
Date Received
December 13, 2017
Date of Event
November 6, 2017
Report Date
November 14, 2017
Manufacturer
MEDLINE INDUSTRIES
Product Code
EHZ
UDI-DI
10080196802081
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

ORAL SWAB STICK WAS USED TO COMPLETE ORAL CARE ON PATIENT. WHEN RN REMOVED THE SWAB, THE SPONGE END REMAINED IN THE BACK OF THE PATIENT'S MOUTH. RN REQUIRED ASSISTANCE TO HOLD PATIENT'S HEAD STILL, USE A LIGHT AND EXTRACT THE SPONGE END WITH TWEEZERS FROM THE BACK OF THE PATIENT'S MOUTH. PATIENT IS INTUBATED AND VENTILATED. SWAB WAS REMOVED WITH NO DAMAGE/HARM TO THE PATIENT. THE SWAB FROM THIS EVENT WAS DISCARDED, BUT THE 3 REMAINING DENTIP ORAL SWABS WERE RETAINED AS WELL AS THE OUTER PACKAGING FOR THE ORAL PACK. ONE ORAL SWAB WAS OPENED FOR INVESTIGATION BY CLINICAL ENGINEERING. THE ADHESIVE BETWEEN THE PLASTIC STICK AND SPONGE DID NOT APPEAR TO HAVE ANY GAPS INITIALLY. WITH A SMALL AMOUNT OF ROTATING AND PULLING FORCE FOR APPROX. 30 SECONDS, THE SPONGE BECAME DETACHED FROM THE PLASTIC HANDLE. IMAGES OF THE HANDLE CAN BE VIEWED UNDER ATTACHMENTS. IT APPEARS THAT ADHESIVE IS ONLY PRESENT ON ONE SIDE OF THE PLASTIC HANDLE. PER SITE REPORTER: MANUFACTURER REPRESENTATIVE WAS EMAILED, AWAITING RESPONSE. WE HAVE THE REMAINING DENTIP SWABS FROM THE SAME PACK, BUT NOT THE BROKEN SWAB FROM THIS EVENT. SWABS AND OUTER PACKAGING WILL BE GIVEN DIRECTLY TO MEDLINE REP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
894972 EXTENDED CARE SUCTION SWAB KIT WITH BIOTENE (DENTIP ORAL SWAB) ORAL CARE, SUCTION SWAB KIT EHZ MEDLINE INDUSTRIES 17-228 10080196802081

Patients

Seq Age Sex Outcome Treatment
1