BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAR/ULCER SYRINGE, PVC-FLEX 3 OZ. (GREEN), STERILE

    MDR report key: 7453046 · Received April 23, 2018

    Report

    Report Number
    1018233-2018-01335
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Report Date
    May 10, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KYZ
    UDI-DI
    00801741049286
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "EAR AND ULCER SYRINGE BARD AND DAVOL ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. COPYRIGHT ©2012 C. R. BARD, INC. ALL RIGHTS RESERVED. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LAWS AND REGULATIONS. CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. DO NOT RESTERILIZE WITH SLIM TIP FOR ASPIRATION AND IRRIGATION, 1 OZ. THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THIS DEVICE. CONTAINS OR PRESENCE OF PHTHALATES (DEHP) CONTAINS OR PRESENCE OF PHTHALATES: DI(2-ETHYLHEXYL)PHTHALATE (DEHP) IS A PLASTICIZER USED IN SOME POLYVINYL CHLORIDE MEDICAL DEVICES. DEHP HAS BEEN SHOWN TO PRODUCE A RANGE OF ADVERSE EFFECTS IN EXPERIMENTAL ANIMALS, NOTABLY LIVER TOXICITY AND TESTICULAR ATROPHY. ALTHOUGH THE TOXIC AND CARCINOGENIC EFFECTS OF DEHP HAVE BEEN WELL ESTABLISHED IN EXPERIMENTAL ANIMALS, THE ABILITY OF THIS COMPOUND TO PRODUCE ADVERSE EFFECTS IN HUMANS IS CONTROVERSIAL. THERE IS NO EVIDENCE THAT NEONATES, INFANTS, PREGNANT AND BREAST FEEDING WOMEN EXPOSED TO DEHP EXPERIENCE ANY RELATED ADVERSE EFFECTS. HOWEVER, A LACK OF EVIDENCE OF CAUSATION BETWEEN DEHP-PVC AND ANY DISEASE OR ADVERSE EFFECT DOES NOT MEAN THAT THERE ARE NO RISKS. SINGLE USE CONTAINS OR PRESENCE OF PHTHALATES (DEHP) CONTAINS OR PRESENCE OF PHTHALATES: DI(2-ETHYLHEXYL)PHTHALATE (DEHP) IS A PLASTICIZER USED IN SOME POLYVINYL CHLORIDE MEDICAL DEVICES. DEHP HAS BEEN SHOWN TO PRODUCE A RANGE OF ADVERSE EFFECTS IN EXPERIMENTAL ANIMALS, NOTABLY LIVER TOXICITY AND TESTICULAR ATROPHY. ALTHOUGH THE TOXIC AND CARCINOGENIC EFFECTS OF DEHP HAVE BEEN WELL ESTABLISHED IN EXPERIMENTAL ANIMALS, THE ABILITY OF THIS COMPOUND TO PRODUCE ADVERSE EFFECTS IN HUMANS IS CONTROVERSIAL. THERE IS NO EVIDENCE THAT NEONATES, INFANTS, PREGNANT AND BREAST FEEDING WOMEN EXPOSED TO DEHP EXPERIENCE ANY RELATED ADVERSE EFFECTS. HOWEVER, A LACK OF EVIDENCE OF CAUSATION BETWEEN DEHP-PVC AND ANY DISEASE OR ADVERSE EFFECT DOES NOT MEAN THAT THERE ARE NO RISKS. DO NOT USE IF PACKAGE IS DAMAGED. MANUFACTURER CAUTION, CONSULT ACCOMPANYING DOCUMENTS. USE BY UNITS DO NOT RESTERILIZE LATEX FREE STERILIZED USING ETHYLENE OXIDE AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY LOT NUMBER CATALOG NUMBER WARNING: REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LAWS AND REGULATIONS. CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EAR AND ULCER SYRINGE HAD A PIECE COME OFF DURING SURGERY WHILE IRRIGATING THE SURGICAL WOUND. THE COMPLAINANT REPORTED THAT THE BROKEN PIECE WAS RETRIEVED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EAR AND ULCER SYRINGE HAD A PIECE COME OFF DURING SURGERY WHILE IRRIGATING THE SURGICAL WOUND. THE COMPLAINANT REPORTED THAT THE BROKEN PIECE WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295678 EAR/ULCER SYRINGE, PVC-FLEX 3 OZ. (GREEN), STERILE EAR AND ULCER SYRINGE KYZ C.R. BARD, INC. (COVINGTON) -1018233 UNK 00801741049286

    Patients

    Seq Age Sex Outcome Treatment
    1