BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8290440 · Received January 30, 2019

    Report

    Report Number
    1710034-2019-00129
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    January 10, 2019
    Report Date
    April 2, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    DHR: ALL REQUIRED CHALLENGE SAMPLES AND TESTING WAS CONDUCTED PER SPECIFICATIONS AND IN ACCORDANCE WITH THE IN-PROCESS SAMPLING AND QUALITY CONTROL PLANS. THERE WAS NO INDICATION OF THE REPORTED DEFECT, AS THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. RECEIVED FOUR 20GA INSYTE AUTOGUARD IV CATHETER UNITS WITHIN PARTIALLY OPENED PACKAGES: 1 PACKAGE FROM LOT: 6102871. 1 PACKAGE FROM LOT: 6195548. 2 PACKAGES FROM LOT: 6348794 ALL COMPONENTS WERE PRESENT AND INTACT WITHIN THE BLISTER PACKS AND THE PACKAGES (BLISTER PACKS) WERE PARTIALLY OPENED AT THE TOP AND BOTTOM ENDS. VISUAL/MICROSCOPIC EXAMINATION: OBSERVED THAT ALTHOUGH THE ALL FOUR UNIT PACKAGES HAD A PARTIALLY OPENED SEAL AT THE TOP AND BOTTOM OF THE BLISTER PACKS AND THE STERILITY BARRIER WAS COMPROMISED AT BOTH ENDS. THE UNIT PACKAGES (BLISTER PACKS) HAD EVIDENCE OF AN ADEQUATE SEAL WITH NO ANOMALIES AT TIME OF MANUFACTURING. THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL TRANSFER. THIS CHARACTERISTIC WAS MET AND THE ANALYSIS REVEALED ADEQUATE TOP WEB ADHESIVE. THE KEY VARIABLES THAT AFFECT SEAL STRENGTH ARE: SEAL TRANSFER/WIDTH AND TOP WEB GLUE. BOTH OF THESE VARIABLES WERE INCLUDED (CONFIRMED) IN THE INVESTIGATION. CONCLUSION(S): BD SUPPLIER OLIVER-TOLAS 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 OLIVER-TOLAS MATERIAL OR ADHESIVE APPLICATION IS THE ROOT CAUSE. CAPA 48637 WAS OPENED TO ADDRESS THE PACKAGE SEAL INTEGRITY COMPLAINTS AND IMPLEMENT CORRECTIVE ACTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BLISTER PACKAGING OF SEVERAL BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS WERE FOUND OPENED DURING STORAGE. LOT NUMBERS: 6102781, 6195548, AND 6348794 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT.

    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 #: 6102781. MEDICAL DEVICE EXPIRATION DATE: 2019-03-31. DEVICE MANUFACTURE DATE: 2016-04-11. MEDICAL DEVICE LOT #: 6195548. MEDICAL DEVICE EXPIRATION DATE: 2019-06-30. DEVICE MANUFACTURE DATE: 2016-07-13. MEDICAL DEVICE LOT #: 6348794. MEDICAL DEVICE EXPIRATION DATE: 2019-11-30. DEVICE MANUFACTURE DATE: 2016-12-22. (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 THE BLISTER PACKAGING OF SEVERAL BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS WERE FOUND OPENED DURING STORAGE. LOT #S 6102781, 6195548, AND 6348794 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81161 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE SECTION H.10. 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other