ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

Report

Report Number: 1119193-2015-00006
Event Type: Injury
Date Received: June 5, 2015
Date of Event: April 8, 2015
Report Date: June 5, 2015
Manufacturer: HOLLISTER INCORPORATED
Product Code: CBH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NV, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE IFU STATES TO "DISCONTINUE THE USE OF THE DEVICE IF REDNESS OR SKIN IRRITATION OCCURS". REDNESS WAS NOTED ON THE UPPER LIP ON APRIL 7 BUT A NEW ANCHORFAST DEVICE WAS STILL APPLIED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE FEMALE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2015 FOR RESPIRATORY DISTRESS. SHE WAS INTUBATED AND AN ANCHORFAST ENDOTRACHEAL TUBE HOLDER WAS APPLIED. ON (B)(6) 2015, THE ANCHORFAST DEVICE WAS REMOVED AND A NEW ANCHORFAST DEVICE WAS APPLIED. AT THE TIME OF THE DEVICE CHANGE, THE NURSE AND THE RESPIRATORY THERAPIST OBSERVED REDNESS ON THE UPPER LIP. ON THE FOLLOWING DAY, (B)(6) 2015, DURING A ROUTINE CHECK OF INTUBATED PATIENTS, A HOLE WAS OBSERVED IN THE PATIENT'S UPPER LIP UNDER THE FOAM BUMPER OF THE ANCHORFAST. THE HOLE WAS STATED TO BE ALL THE WAY THROUGH THE UPPER LIP. PLASTICS WAS CALLED AND THE LIP WAS SUTURED. THE PATIENT WAS EXTUBATED ON (B)(6) 2015 AND TRANSFERRED TO HOSPICE ONE WEEK LATER. THE SUTURED AREA WAS NOTED TO APPEAR FINE. THE CLINICAL COORDINATOR STATED THAT THE ANCHORFAST DEVICE WAS TOO TIGHT AND DID NOT HAVE THE REQUIRED 2 FINGER WIDTHS OF SPACE BETWEEN THE NECK STRAP AND THE BACK OF THE PATIENT'S HEAD. IT IS UNKNOWN IF THE DEVICE WAS APPLIED TOO TIGHTLY OR IF CHANGING PATIENT CONDITIONS CAUSED THE TIGHTNESS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
364037	ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER	ANCHORFAST ETAD	CBH	HOLLISTER INCORPORATED	9799

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR		Required Intervention