BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VISITEC

    MDR report key: 1982791 · Received January 6, 2011

    Report

    Report Number
    1211998-2010-00007
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 29, 2010
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL (FORMERLY BD OPHTHALMIC SYSTEMS)
    Product Code
    HMX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    FA-10-004-112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A RECALL WAS INITIATED ON (B)(4) 2010 TO RECALL PRODUCT FROM THE FIELD. A REPORT WAS FORWARDED TO THE FDA ON (B)(4) 2010. ALL RECALLED PRODUCT WILL BE SCRAPPED. INVESTIGATION FOUND THE PLASTICIZERS IN THE TEKNOR APEX PVC TUBING MIGRATE OVER TIME INTO THE K-RESIN OVER MOLD ON THE INJECTOR. THE PLASTICIZERS CAUSE THE K-RESIN TO DEGRADE AND DISTORT. THE DISTORTION BLOCKS THE FLUID PATH THROUGH THE LUMEN. RETURNED COMPLAINT SAMPLES WERE CONFIRMED TO BE BLOCKED DUE TO THE DEGRADATION OF THE K-RESIN OVER MOLD. THE PREVIOUS PVC TUBING, COLORITE 7077 DID NOT DEGRADE THE K-RESIN OVER MOLD. FURTHER INVESTIGATION FOUND THAT THE PVC TUBING TYPE WAS CHANGED TO TEKNOR APEX PVC ON (B)(6) 2010 DUE TO SUPPLIER AVAILABILITY OF THE COLORITE 7077 PVC TUBING. OUR REVIEW AND TESTING OF THE TEKNOR APEX PVC PRIOR TO RELEASE APPEARED THAT THIS PVC TYPE WAS EQUIVALENT TO COLORITE 7077. WE RECEIVED INFORMATION THAT THE NEW QUALIFIED SUPPLIER WILL BE ABLE TO OBTAIN THE FORMER COLORITE 7077 COMPOUND AND WE WILL RETURN TO THIS AS REPLACEMENT PVC TUBING. FIVE UNSUCCESSFUL ATTEMPTS SINCE (B)(6) WERE MADE TO CONTACT THE CUSTOMER. WE WILL CONTINUE OUR EFFORTS TO OBTAIN MORE INFORMATION FROM THE CUSTOMER AND PROVIDE A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    (B)(4). THE PRODUCT FAILED. AT THE BASE OF THE CANNULA WITHIN THE TUBING A BUBBLE FORMED, MAKING IT IMPOSSIBLE FOR THE OIL TO FLOW. THEREBY THE PRESSURE IN THE PATIENT'S EYE WENT TO ZERO. THIS IS ONE OF TWO ISSUES THAT OCCURRED. ON THE SECOND CASE ON THE SAME DAY, THE BASE OF THE CANNULA HAD ISSUES WHERE THE OIL WAS LEAKING FROM THE BASE OF THE TUBE AND METAL. PER CONTACT, THIS IS THE FIRST TIME THE LEAK OCCURRED, BUT THE BUBBLE ISSUE HAS HAPPENED A TOTAL OF 3 TIMES. EACH TIME WITH THE SAME SURGEON; DR (B)(6). PER CONTACT, SURGEON STATED THAT THE PRODUCT APPEARS DIFFERENT THAN IN THE PAST. FROM THE TUBING COLOR AND FLEXIBILITY OF THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD VISITEC HIGH VISCOSITY INJECTOR 6MM HMX BEAVER-VISITEC INTERNATIONAL (FORMERLY BD OPHTHALMIC SYSTEMS) NA 0211586

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention