BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24G X 0.75IN (0.7 X 19 MM) ANGIOCATH

    MDR report key: 8573296 · Received May 2, 2019

    Report

    Report Number
    9610048-2019-00164
    Event Type
    Malfunction
    Date Received
    May 2, 2019
    Date of Event
    January 6, 2019
    Report Date
    May 1, 2019
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903811120
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD WAS UNABLE TO VERIFY ANY CATHETER TIP BURR, THE SAMPLES RETURNED WERE WITHIN SPECIFICATION. DURING INSPECTION IT WAS FOUND THE SAMPLES HAD EXCESS SILICONE ON THE CATHETER AND THE OPEN UNIT FROM LOT 7172782 HAD A FOREIGN MATTER ON THE NEEDLE. FOURIER-TRANSFORM INFRARED SPECTROSCOPY DETERMINED THIS MATERIAL IS MOST LIKELY THE TOP WEB OF THE BLISTER PACK OF THE PRODUCT. SILICONE: IT SHOULD BE NOTED THAT THIS SILICONE DOES NOT CAUSE DAMAGE TO THE USER AND IS USED TO AID IN THE SLIPPAGE OF THE CATHETER DURING VENIPUNCTURE. THE ROOT CAUSE OF THIS ISSUE ON THE CATHETER IS CAUSED BY THE EXCESSIVE AMOUNT OF SILICONE THAT IS DISPENSED DURING THE SILICONIZATION OF THE CATHETER TIP TIPPING AND FINAL ASSEMBLY PROCESS. A CORRECTIVE ACTION PROJECT HAS BEEN INITIATED TO INVESTIGATE THE ISSUE. FOREIGN MATTER: THE FOREIGN MATTER ENCOUNTERED IS A SUBSTANCE WHICH MAY ORIGINATE FROM THE PACKAGING PAPER ITSELF. THE SUPPLIER FOR THE PACKAGING PAPER WAS CHANGED, SO IT IS BELIEVED THAT THIS CAN PREVENT THIS ISSUE. INVESTIGATION CONCLUSION: AS PER REQUEST, FTIR ANALYSIS WAS COMPLETED ON THE WHITE PIECE OF MATERIAL OBSERVED ON THE CANNULA. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY THE TOP WEB OF THE BLISTER PACK OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 24G X 0.75IN (0.7 X 19 MM) ANGIOCATH EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CATHETER TIP WAS BURR. THE FOLLOWING INFORMATION RESULTED FROM INVESTIGATION OF THE RETURNED SAMPLE: THE OPENED UNIT FROM CATALOG NUMBER 381112, LOT NUMBER 7172782 HAS SOME TYPE OF FOREIGN MATERIAL ON THE NEEDLE. THE 16 UNUSED UNITS FROM CATALOG NUMBER 381112, LOT NUMBER 7172782 ALL HAVE SILICONE DROPLETS ON THE CATHETER TUBING BUT I DID NOT SEE ANY CATHETER OR NEEDLE TIP DAMAGE. THE TWO UNUSED UNITS FROM CATALOG NUMBER 381112, LOT NUMBER 7150528 ALSO HAVE SILICONE DROPLETS ON THEM BUT I DID NOT SEE ANY CATHETER OR NEEDLE TIP DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365247 24G X 0.75IN (0.7 X 19 MM) ANGIOCATH INTERVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7172785 00382903811120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other