BEUDAMED
    FDA Adverse Event Other Summary report: N

    DALE STABILOCK ENDOTRACHEAL TUBE HOLDER

    MDR report key: 2310647 · Received October 7, 2011

    Report

    Report Number
    1214422-2011-00005
    Event Type
    Other
    Date Received
    October 7, 2011
    Date of Event
    June 21, 2010
    Report Date
    April 29, 2011
    Manufacturer
    DALE MEDICAL PRODUCTS, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DALE MEDICAL PRODUCTS, INC IS REPORTING THIS EVENT AT THE RECOMMENDATION OF AN FDA INVESTIGATOR DURING AN INSP. THIS EVENT WAS ORIGINALLY ENTERED INTO OUR COMPLAINT DATABASE AS A "CUSTOMER REQUEST FOR ADD'L IN-SERVICING," REGARDING THE PROPER USE OF THE DALE 270 DEVICE. THE USER FACILITY HAD DOCUMENTED 6 CASES OF SKIN BREAKDOWN OVER AN 8 WEEK PERIOD WHERE THERE HAD BEEN NO ISSUES IN THE PREVIOUS YEAR. A MEETING WITH 8 CLINICIANS FROM THE USER FACILITY WAS HELD BY DALE PERSONNEL. ADD'L IN-SVC TRAINING WAS CARRIED OUT OVER 7 DAYS FOR DAY AND NIGHT STAFF, NURSING AND RESPIRATORY THERAPISTS. INCONSISTENCIES IN THE APPLICATION AND USE OF THE DALE 270 DEVICE WERE NOTED DURING THE MEETING AND IN-SVC TRAINING. DALE MEDICAL HAS SOLD OVER (B)(4) OF THESE PRODUCTS SINCE (B)(4) 2009, WITH ONLY (B)(4) ISSUES SIMILAR TO THIS ONE, WHERE THE FACILITY WAS LOOKING FOR ADD'L INFO OR IN-SVC TRAINING. NO ADD'L REPORTS OF SKIN BREAKDOWN HAVE BEEN REPORTED BY THE USER FACILITY SINCE THE IN-SVC TRAINING IN (B)(6) 2010.

    Description of Event or Problem · 1

    (NOTE: THIS EVENT IS BEING REPORTED NOW AS A RESULT OF AN FDA INSP AT OUR FACILITY (DALE MEDICAL PRODUCTS, INC) ON (B)(6) 2011. OUR INITIAL REVIEW OF THIS ISSUE CONCLUDED THAT THIS WAS NOT A REPORTABLE EVENT. HOWEVER, IT WAS THE OPINION OF THE INVESTIGATOR THAT THESE WERE REPORTABLE). ON (B)(6) 2010, DALE MEDICAL RECEIVED A CALL FROM A HEALTHCARE FACILITY IN (B)(6), WHERE THEY SAID THAT THEY HAVE USED THE DALE 270 ET HOLDER CONSISTENTLY FOR ABOUT 1 YEAR, BUT HAVE RECENTLY BEEN EXPERIENCING SKIN BREAKDOWN ISSUES; SIX BREAKDOWNS IN AN EIGHT WEEK PERIOD. THE USER FACILITY REPORTED THAT THE PROBLEM IS NOT WITH THE ADHESIVE PART OF THE DEVICE, BUT WITH THE PLASTIC PIECE THAT IS PINCHING THE LIP. WHEN ASKED ABOUT WEIGHT ISSUES WITH THE VENTILATOR ARMS, THE USER FACILITY REPORTED THAT THEY HAVE HAD RECENT ISSUES WITH THE VENTILATOR ARMS IN SICU, BUT THE REPORTED ISSUE WAS NOT LIMITED TO (B)(6). ON (B)(6) 2010, DALE PERSONNEL VISITED AND MET WITH 8 CLINICIANS OF VARIOUS DISCIPLINES AT THE USER FACILITY. THE MEETING AT THE USER FACILITY COVERED ALL THE APPROPRIATE TOPICS SUCH AS: USE OF VENTILATOR ARMS. FREQUENCY OF ROTATING ET TUBE FROM SIDE TO SIDE. TIGHTNESS OF THE NECK BAND. SKIN PREP FOR THE ADHESIVE BASE. THE OUTCOME OF THE MEETING WAS THAT FOUR IN-SVC TRAINING SESSIONS WERE SCHEDULED IN (B)(6) 2010, FOR BOTH NIGHT AND DAY STAFF. IN-SVC TRAINING WAS PROVIDED BY DALE PERSONNEL AT THE USER FACILITY ON (B)(6) 2010 AND (B)(6) 2010 FOR THE NIGHT STAFF. IN-SVC TRAINING WAS PROVIDED BY DALE PERSONNEL ON (B)(6) 2010 FOR THE DAY STAFF. TRAINING WAS PROVIDED TO NURSING AS WELL AS RESPIRATORY THERAPISTS. NO ADD'L REPORTS OF SKIN BREAKDOWN HAVE BEEN REPORTED BY THE USER FACILITY SINCE THE IN-SVC TRAINING IN (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DALE STABILOCK ENDOTRACHEAL TUBE HOLDER CBH, REG 868.5770 CBH DALE MEDICAL PRODUCTS, INC. 270

    Patients

    Seq Age Sex Outcome Treatment
    1 Other