BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 G X 1 IN. (1.1 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 6960074 · Received October 18, 2017

    Report

    Report Number
    1710034-2017-00296
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    September 26, 2017
    Report Date
    November 7, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K984059
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: LOT 6070864: A TOTAL OF (B)(4) UNITS WERE BUILT ON AFA LINE 10 AND PACKAGED ON LINE 11FROM MAR 17, 2016 THRU MAR 21, 2016. 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. IN PROCESS SAMPLES FOR BLISTER THICKNESS, BAD SEAL/CUT/HOLES, SEAL TRANSFER WIDTH AND PACKAGE LEAK TEST WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND. LOT 6210732: A TOTAL OF (B)(4) UNITS WERE BUILT ON AFA LINE 9 AND PACKAGED ON LINE 11 FROM JUL 28, 2016 THRU AUG 1, 2016. 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. IN PROCESS SAMPLES FOR BLISTER THICKNESS, BAD SEAL/CUT/HOLES, SEAL TRANSFER WIDTH AND PACKAGE LEAK TEST WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND. QN / SAP DATABASE REVIEW: NO. REASON: A REVIEW OF THE QN/SAP DATABASE IS NOT REQUIRED FOR LEVEL A INVESTIGATION PER (B)(4). THE PEURA (END USER RISK ANALYSIS): YES]] REASON: THE PEURA IS REQUIRED FOR ALL MDR REPORTABLE INVESTIGATIONS. FINDINGS: (B)(4) VERSION I WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. VISUAL ANALYSIS: OBSERVATIONS AND TESTING: RECEIVED A TOTAL OF 2 INSYTE AUTOGUARD UNITS, 1 FROM LOT NUMBER 6210732 AND THE OTHER FROM LOT NUMBER 6070864. BOTH OF THE UNITS RECEIVED (2) WERE PARTIALLY OPEN AT BOTH ENDS. *NOTE: THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL TRANSFER. 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. TEST DESCRIPTION: METHOD NO.: RESULTS: VISUAL/MICROSCOPIC , N/A, SEE OBSERVATIONS AND TESTING. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: YES; ALTHOUGH THE DEFECT WAS CONFIRMED, THE UNITS EVALUATED FOR THIS INCIDENT PASSED THE MANUFACTURING SPECIFICATION REQUIREMENTS. CONCLUSION: THE DEFECT STATED IN THE EVENT DESCRIPTION WAS CONFIRMED WITH THE RETURNED UNITS. EVEN THOUGH THE PACKAGES CAME PARTIALLY OPENED, ALL THE PROCESSES CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL STRENGTH ARE: SEAL TRANSFER AND TOP WEB GLUE, MEASURED WITHIN SPECIFICATION. NO ANOMALIES WERE FOUND. DID THE EVALUATION CONFIRM THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? YES; THE FAILURE THAT THE CUSTOMER EXPERIENCED WAS CONFIRMED. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO; IT WAS NOT NECESSARY TO ACHIEVE REPRODUCTION OF THE CUSTOMER¿S EXPERIENCE AS THE DEFECT WAS CONFIRMED. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT. ROOT CAUSE: ROOT CAUSE: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE. COMMENT: EVEN THOUGH THE PACKAGES CAME PARTIALLY OPENED, THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT. THE PACKAGING OPERATORS ARE RESPONSIBLE TO VERIFY THE SEAL TRANSFER/WIDTH AND THAT PACKAGES ARE ¿WATER LEAK TESTED¿ EVERY HOUR. THESE ATTRIBUTE INSPECTIONS ARE DONE TO VERIFY THAT THE PACKAGES ARE SEALED ADEQUATELY PRIOR TO PLACING THEM WITHIN THE DISPENSER. THIS ISSUE IS CURRENTLY BEING INVESTIGATED BY CAPA (B)(4). CORRECTIVE ACTION / CAPA #: CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE. OTHER ACTIONS TAKEN (IF APPLICABLE): PACKAGING OPERATORS ARE RESPONSIBLE TO VERIFY PACKAGE INTEGRITY, INCLUDING THE VERIFICATION THAT THE PACKAGES ARE ADEQUATELY SEALED. IN ADDITION, PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING AND PACKAGING PROCESS WITH PRESCRIBED ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS TO ENSURE ANY GROSS PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION(S) ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6070864, MEDICAL DEVICE EXPIRATION DATE: 2019-02-28, DEVICE MANUFACTURE DATE: 2016-03-10. MEDICAL DEVICE LOT #: 6210732, MEDICAL DEVICE EXPIRATION DATE: 2019-07-31, DEVICE MANUFACTURE DATE: 2016-07-28. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING OF SEVERAL 20 G X 1 IN. (1.1 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER(S) WAS OPENED BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738117 20 G X 1 IN. (1.1 MM X 25 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