BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X 1 IN. (1.3 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 6966511 · Received October 20, 2017

    Report

    Report Number
    1710034-2017-00295
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    September 26, 2017
    Report Date
    October 13, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7013778. MEDICAL DEVICE EXPIRATION DATE: 2019-12-31, DEVICE MANUFACTURE DATE: 2017-01-16, MEDICAL DEVICE LOT #: 6348825. MEDICAL DEVICE EXPIRATION DATE: 2019-11-30, DEVICE MANUFACTURE DATE: 2016-12-22, MEDICAL DEVICE LOT #: 6110773, MEDICAL DEVICE EXPIRATION DATE: 2019-03-31, DEVICE MANUFACTURE DATE: 2016-04-19. (B)(6). INVESTIGATION: INVESTIGATION SUMMARY: THE DEFECT OF PACKAGE DAMAGED-DEFECTIVE-OTHER AS STATED IN EVENT DESCRIPTION WAS CONFIRMED WITH THE RETURNED UNITS. NO ANOMALIES WERE FOUND AND ALL THE PROCESS CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL STRENGTH (SEAL TRANSFER AND TOP WEB GLUE) WERE MET. THE UNITS WERE ACCEPTABLE PER SPECIFICATION REQUIREMENTS. HOWEVER, A CAPA HAS BEEN OPENED TO INVESTIGATE THE PACKAGE OPEN SEAL DEFECTS AND IMPLEMENT CORRECTIVE ACTIONS. INVESTIGATION CONCLUSION: THE FAILURE THAT THE CUSTOMER EXPERIENCED WAS CONFIRMED. IT WAS NOT NECESSARY TO ACHIEVE REPRODUCTION OF THE CUSTOMER¿S EXPERIENCE, AS THE DEFECT WAS CONFIRMED. PER REVIEW OF THE DHR FOR LOT #¿S 7013778, 6110773, 6348825, 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. IN PROCESS SAMPLES (INCLUDED BUT NOT LIMITED) BLISTER THICKNESS, PERFORATION TEST, SEAL TRANSFER WIDTH AND PACKAGE LEAK TEST WERE PERFORMED THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. VISUAL ANALYSIS OBSERVATIONS AND TESTING: RECEIVED A TOTAL OF 7 IAG 14GA UNITS OF WHICH 3 WERE FROM LOT NUMBER 7013778, 3 UNITS FROM LOT 6110773 AND 1 UNIT FROM LOT 6348825. LOT 7013778: 1 UNIT WAS PARTIALLY OPEN AT ONE END. 2 UNITS WERE PARTIALLY OPEN AT BOTH ENDS. LOT 6110773: ALL OF THE UNITS RECEIVED (3) WERE PARTIALLY OPEN AT BOTH ENDS. LOT 6348825: THE UNIT RECEIVED (1) WAS PARTIALLY OPEN AT ONE END. A SAMPLE SIZE OF ONE UNIT PER LOT NUMBER WAS TAKEN AND WAS ANALYZED UNDER UV LIGHT. THE ADHESIVE USED TO SEAL THE TOP AND BOTTOM WEBS IS UV FLUORESCENT. THE ANALYSIS REVEALED AN ADEQUATE OF TOP WEB ADHESIVE. THE KEY VARIABLES THAT AFFECT SEAL STRENGTH ARE: SEAL TRANSFER/WIDTH AND PAPER TOP WEB GLUE. BOTH OF THESE VARIABLES WERE INCLUDED IN THE OBSERVATIONS. THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL TRANSFER. ALTHOUGH THE DEFECT WAS CONFIRMED, THE UNITS EVALUATED FOR THIS INCIDENT PASSED THE MANUFACTURING SPECIFICATION REQUIREMENTS. ROOT CAUSE DESCRIPTION: ALTHOUGH THE PACKAGES WERE RECEIVED OPENED / PARTIALLY PEELED, THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT. CAPA SEAL DEFECT HAS BEEN OPENED TO INVESTIGATE THE PACKAGE OPEN SEAL DEFECTS AND IMPLEMENT CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL PACKAGES OF 22 G X 1 IN. (1.3 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WERE DAMAGED BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743711 22 G X 1 IN. (1.3 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other