BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC GLOBAL PNK 20GA X 1.16IN

    MDR report key: 8975224 · Received September 9, 2019

    Report

    Report Number
    1710034-2019-00978
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Date of Event
    August 20, 2019
    Report Date
    October 15, 2019
    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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 7220674, D.4. MEDICAL DEVICE EXPIRATION DATE: 7/31/2020 AND H.4. DEVICE MANUFACTURE DATE: 8/8/2017. D.4. MEDICAL DEVICE LOT #: 7299860, D.4. MEDICAL DEVICE EXPIRATION DATE: 9/30/2020 AND H.4. DEVICE MANUFACTURE DATE: 10/26/2017. D.4. MEDICAL DEVICE LOT #: 8071715, D.4. MEDICAL DEVICE EXPIRATION DATE: 3/12/2018 AND H.4. DEVICE MANUFACTURE DATE: 2/28/2021. D.4. MEDICAL DEVICE LOT #: 7244612, D.4. MEDICAL DEVICE EXPIRATION DATE: 8/31/2020 AND H.4. DEVICE MANUFACTURE DATE: 9/1/2017. D.4. MEDICAL DEVICE LOT #: 7089512, D.4. MEDICAL DEVICE EXPIRATION DATE: 4/3/2017 AND H.4. DEVICE MANUFACTURE DATE: 3/31/2020. D.4. MEDICAL DEVICE LOT #: 7059847, D.4. MEDICAL DEVICE EXPIRATION DATE: 2/29/2020 AND H.4. DEVICE MANUFACTURE DATE: 3/6/2017. D.4. MEDICAL DEVICE LOT #: 7349907, D.4. MEDICAL DEVICE EXPIRATION DATE: 2/29/2020 AND H.4. DEVICE MANUFACTURE DATE: 3/6/2017. H.6. INVESTIGATION SUMMARY: RECEIVED 11 IAG 20GA PACKAGES AS FOLLOWS: 7220674 = (B)(4) UNITS, 7059847 = (B)(4) UNITS, 7089512 = (B)(4) UNIT, 7244612 = (B)(4) UNITS, 7299860 = (B)(4) UNIT, 7349907 = (B)(4) UNIT AND 8071715 = (B)(4) UNIT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. VISUAL EVALUATION: 7220674 AND 7349907: THE PACKAGES WERE RECEIVED PARTIALLY OPEN AT BOTH ENDS. THE NEEDLE IN ONE OF THE UNITS FOR LOT 7220674 WAS FULLY RETRACTED. 7059847,7089512, 7244612, 7299860 AND 8071715: THE PACKAGES WERE PARTIALLY OPEN AT ONE END. 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. CONCLUSION(S): SUPPLIER ¿ DEFECTIVE MATERIAL 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 MATERIAL OR ADHESIVE APPLICATION IS THE ROOT CAUSE. CAPA 48637 WAS OPENED TO INVESTIGATE. THE LOTS ASSOCIATED WITH THIS INCIDENT WERE BUILT BEFORE THE CAPA IMPLEMENTATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE INSYTE AUTOG BC GLOBAL PNK 20GA X 1.16IN THE PACKAGE WAS OPENING. THERE WERE 15 PACKAGES WITH THIS CONDITION. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE PACKAGES BECAME OPENED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE INSYTE AUTOG BC GLOBAL PNK 20GA X 1.16IN THE PACKAGE WAS OPENING. THERE WERE 15 PACKAGES WITH THIS CONDITION. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE PACKAGES BECAME OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768129 INSYTE AUTOG BC GLOBAL PNK 20GA X 1.16IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other