BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BENEHOLD MEDICAL TAPE STRIPS

    MDR report key: 2652075 · Received April 24, 2012

    Report

    Report Number
    3005360738-2012-00001
    Event Type
    Injury
    Date Received
    April 24, 2012
    Date of Event
    March 23, 2012
    Report Date
    March 23, 2012
    Manufacturer
    AVERY DENNISON BELGIE, BVBA
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GENERAL COMMUNICATION WAS ALSO RECEIVED FROM THE CUSTOMER WITH COMMENTS THAT THE DEVICE WAS NOT AS STICKY AS DESIRED. THIS COMMENT WAS NOT SPECIFICALLY MENTIONED WITH THIS EVENT. THE MFR IS NOT IDENTIFYING THIS EVENT AS A PRODUCT PROBLEM. AS PER THE COMPLAINT INVESTIGATION, THE MFG PROCESS, RETAINED PRODUCT SAMPLES, AND ANY PRODUCT RETRIEVED FROM THE CUSTOMER WERE EVALUATED. THE INVESTIGATION WAS CONCLUDED AND SHOWED THAT THE PRODUCT HAD MET SPECS. (B)(4).

    Description of Event or Problem · 1

    PRODUCT IS USED TO ANCHOR VENOUS NEEDLES DURING DIALYSIS THERAPY. DURING THERAPY FOR PT (B)(6), THE PT REPORTED NOT FEELING WELL AT 9:56 AM. VENOUS DISLODGEMENT WAS OBSERVED AS WELL 500CC BLOOD LOSS. PT WAS ALERT AND NORMAL. PRESSURE APPLIED TO INSERTION SITE, NORMAL SALINE ADMINISTERED TO SUPPORT BLOOD PRESSURE. OXYGEN ADMINISTERED. BLOOD PRESSURE RECORDED AS 88/54 AT 9:58 AM AND 124/55 WITH A PULSE OF 71 AT 10:02 AM. PT SENT TO HOSP VIA AMBULANCE (EMS ACTIVATED AT 9:58 AM). ADD'L INFO FROM UF REPORT: DURING DIALYSIS AT 9:56 AM PT STATED THAT HE WAS NOT FEELING WELL. NURSE NOTED VENOUS NEEDLE HAS DISLODGED AND APPROX 500ML OF BLOOD WAS POOLED UNDER THE CHAIR. PT WAS A&OX3. PRESSURE APPLIED TO THE VENOUS NEEDLE INSERTION SITE, NORMAL SALINE ADMINISTERED FOR BP SUPPORT, OXYGEN APPLIED. BP 88/54 AT 10:00 AM AND 124/55 PULSE 71 AT 10:02 AM. EMS ACTIVATED AT 9:58 PT TO THE HOSP VIA EMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BENEHOLD MEDICAL TAPE STRIPS TAPE ON A SHEET KGX AVERY DENNISON BELGIE, BVBA 9533186

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R JMS WINGEATER FISTULA NEEDLE: