BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8047513 · Received November 7, 2018

    Report

    Report Number
    1710034-2018-00793
    Event Type
    Malfunction
    Date Received
    November 7, 2018
    Date of Event
    September 3, 2018
    Report Date
    January 3, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED A TOTAL OF 2 IAG UNITS OF WHICH 1 WAS FROM LOT NUMBER 7102795 AND THE OTHER FROM LOT 6312709. ALL COMPONENTS WITHIN WERE INTACT. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF PACKAGE SEAL INTEGRITY POOR / QUESTIONABLE WITH LOT #7102795 AND 6312709 REGARDING ITEM #381834. DHR REVIEW FOR LOT # 7102795: THE PRODUCT WAS BUILT ON AFA LINE 6 FROM 18APR2017 THROUGH 19APR2017. PACKAGING LINE 9 ON 22APR2017 FOR THE AMOUNT OF (B)(4) EA. NO QNS WERE INITIATED DURING PRODUCTION. ALL CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WERE PERFORMED AND ALL PASSED PER SPECIFICATIONS. DHR REVIEW FOR LOT # 6312709: THE PRODUCT WAS BUILT ON AFA LINE 7 FROM 9NOV2016 THROUGH 16NOV2016. PALLETS 1 AND 2 WERE PACKAGED ON PKG LINE 8 ON 11NOV2016, PALLETS 3-16 WERE PACKAGED ON PKG 9 FROM 12NOV2016 THROUGH 16NOV2016 AND PALLET 17 ON PKG LINE 11 ON 10JAN2017. 1 NON-RELATED QN (200668424 FOR SHALLOW PLUGS) WAS INITIATED WHERE DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTIONS WERE APPLIED AS PER CONTROL PLAN. ALL OTHER CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WERE PERFORMED AND ALL PASSED PER SPECIFICATIONS. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. BOTH OF THE UNITS RECEIVED WERE PARTIALLY OPEN AT BOTH END. INVESTIGATION CONCLUSION: THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL WIDTH WITH ADHESIVE TRANSFER FROM THE TOP WEB PAPER TO THE BOTTOM WEB FILM. THIS CHARACTERISTIC WAS MET. THE KEY VARIABLES THAT AFFECT THE PACKAGING SEAL ARE SEAL TRANSFER/WIDTH AND TOP WEB ADHESIVE PRESENCE. BOTH OF THESE VARIABLES WERE INCLUDED IN THE INVESTIGATION. ROOT CAUSE DESCRIPTION: SUPPLIER ¿ DEFECTIVE MATERIAL. BD SUPPLIER (B)(4) (OT) 29LP USES A STANDARD REINFORCED PAPER THAT IS COMMON TO MANY OTHER SUPPLIERS, BUT THE ADHESIVE TYPE AND APPLICATION IS SPECIFIC TO OLIVER-TOLAS. THERE IS SUFFICIENT EVIDENCE TO DEMONSTRATE THE OT MATERIAL OR ADHESIVE APPLICATION IS THE ROOT CAUSE. RATIONALE: CAPA 48637 WAS OPENED TO INVESTIGATE THE PACKAGE SEAL INTEGRITY COMPLAINTS AND IMPLEMENT CORRECTIVE ACTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS WERE FOUND WITH OPEN PACKAGING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    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 #: 7102795. MEDICAL DEVICE EXPIRATION DATE: 2020-03-31. DEVICE MANUFACTURE DATE: 2017-04-12 MEDICAL DEVICE LOT #: 6312709. MEDICAL DEVICE EXPIRATION DATE: 2019-10-31. DEVICE MANUFACTURE DATE: 2016-11-08. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS WERE FOUND WITH OPEN PACKAGING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888655 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other