BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X 1.00 IN. (0.9 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 6966953 · Received October 20, 2017

    Report

    Report Number
    1710034-2017-00267
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    September 27, 2017
    Report Date
    October 3, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815235
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7122821, MEDICAL DEVICE EXPIRATION DATE: 2020-04-30, DEVICE MANUFACTURE DATE: 2017-05-03. MEDICAL DEVICE LOT #: 7059825, MEDICAL DEVICE EXPIRATION DATE: 2020-04-30, DEVICE MANUFACTURE DATE: 2017-05-03. INVESTIGATION SUMMARY: LOT 7122821- THE LOT WAS BUILT ON AFA LINE 5 FROM MAY 9, 2017 THROUGH MAY 15, 2017. PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SET-UP AND IN PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. SET-UP AND IN PROCESS SAMPLES (INCLUDING BUT NOT LIMITED TO) FOR DAMAGED COMPONENT (GRIP, BUTTON, SPRING, HUB), NEEDLE RETRACTION BY BUTTON ACTIVATION AND ADHESIVE OVERFILLED/DRIP AS WELL AS PERIODIC CLEANING/ALIGNMENT OF THE GLUE GRIPPERS WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND. LOT 7059825- THE LOT WAS BUILT ON AFA LINE 5 AND PACKAGED ON PKG LINE 10 FROM MAR 3, 2017 THROUGH MAR 15, 2017. PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SET-UP AND IN PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. SET-UP AND IN PROCESS SAMPLES (INCLUDING BUT NOT LIMITED TO) FOR DAMAGED COMPONENT (GRIP, BUTTON, SPRING, HUB), NEEDLE RETRACTION BY BUTTON ACTIVATION AND ADHESIVE OVERFILLED/DRIP AS WELL AS PERIODIC CLEANING/ALIGNMENT OF THE GRIPPERS WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND. OBSERVATIONS AND TESTING: RECEIVED A TOTAL OF 177 UNITS OF WHICH 97 UNIT BELONGED TO LOT NUMBER 7122821 AND 80 UNITS TO LOT 72059825. ALL UNITS WERE RECEIVED WITHIN SEALED AND INSIDE THEIR RESPECTIVE DISPENSERS, THEIR COMPONENTS WERE INTACT. NO MECHANICAL/PHYSICAL DAMAGE WAS OBSERVED TO THE SPRING, NEEDLE HUB OR GRIP. THERE WERE NO MISSING COMPONENTS OR EVIDENCE OF GLUE ON THE BUTTONS OR HUBS. FUNCTIONAL TEST (NEEDLE RETRACTION): THE NEEDLE COVERS WERE REMOVED, MANUALLY ROTATED THE CATHETER TIPS 360 DEGREES, THE CATHETER TUBING DID NOT ¿CANDY CANNED¿. THE WHITE BUTTONS WERE DEPRESSED AND THE NEEDLES DID RETRACT MEETING NO RESISTANCE. RETRACTION WAS SUCCESSFUL. NO MECHANICAL/PHYSICAL DAMAGE WAS OBSERVED AND THE UNITS DEMONSTRATED A SUCCESSFUL RETRACTION WHEN TESTED IN THE LABORATORY ENVIRONMENT. INVESTIGATION CONCLUSION: THE DEFECT OF NEEDLE RETRACTION FAILURE AS STATED IN THE EVENT DESCRIPTION COULD NOT BE CONFIRMED WITH THE REPRESENTATIVE UNITS RETURNED FOR EVALUATION AND TESTING. THE DEFECT OF NEEDLE RETRACTION FAILURE THAT THE CUSTOMER EXPERIENCED WAS NOT CONFIRMED WITH THE UNITS RECEIVED FOR EVALUATION AND TESTING. REPRODUCTION OF THE FAILURE THAT THE CUSTOMER EXPERIENCED COULD NOT BE ACHIEVED WITH THE EVALUATION AND TESTING PERFORMED ON THE UNITS RECEIVED IN THE LABORATORY ENVIRONMENT. ROOT CAUSE DESCRIPTION: THE RETURNED REPRESENTATIVE UNITS DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED. THE DEFECT DESCRIBED IN THE EVENT DESCRIPTION COULD NOT BE CONFIRMED OR REPLICATED WITH THE RETURNED REPRESENTATIVE UNITS. THE ACTUAL UNIT DESCRIBED IN THE INCIDENT REPORT WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY DEVICE DID NOT WORK PROPERLY ON A 22 G X 1.00 IN. (0.9 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THIS HAS HAPPENED 8-10 TIMES THAT THE NEEDLE DID NOT RETRACT CORRECTLY AFTER USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743776 22 G X 1.00 IN. (0.9 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10. 30382903815235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other