BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8921920 · Received August 22, 2019

    Report

    Report Number
    1710034-2019-00917
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    July 30, 2019
    Report Date
    September 24, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RECEIVED 400 UNUSED IAG 24GA UNITS IN SEALED PACKAGES FROM MATERIAL NUMBER 381812, LOT NUMBER 9002870. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. 10 PHOTOS WERE ALSO SUBMITTED FOR REVIEW. 1 DISPLAYED TWO SHIPPERS WITH LABELS TO IDENTIFY THE PRODUCT. 5 DISPLAYED A PACKAGE WITH PRODUCT AND A SMALL BLACK SPECK OF FM. 6 DISPLAYED A PACKAGE WITH PRODUCT AND A SMALL BLACK SPECK OF FM. 7 DISPLAYED A PACKAGE WITH PRODUCT AND SEVERAL SMALL SPECKS OF FM. 8 DISPLAYED A PACKAGE WITH PRODUCT AND A SMALL SPECK OF FM. 9 DISPLAYED A PACKAGE WITH PRODUCT AND A VERY SMALL SPECK OF FM. 10 DISPLAYED THREE PACKAGES WITH PRODUCT AND A VERY SMALL SPECK OF FM. 11 DISPLAYED A PACKAGE WITH PRODUCT AND A SPECK OF FM. 12 DISPLAYED TWO PACKAGES WITH PRODUCT AND A SPECK OF FM. 13 DISPLAYED THREE PACKAGES WITH PRODUCT AND A VERY SMALL SPECK OF FM. VISUAL/MICROSCOPIC EVALUATION WAS PERFORMED ON ALL 400 UNITS. FM WAS OBSERVED ON SEVEN OF THE UNITS. UNIT 1 ¿ SMALL BLACK SPECK SEALED BETWEEN THE TOP AND BOTTOM WEBS AND APPROXIMATELY .09 SQUARE MILLIMETERS. UNIT 2 ¿ SMALL BLACK SPECK ON THE GRIP INSIDE OF THE SEALED PACKAGE AND APPROXIMATELY .09 SQUARE MILLIMETERS. UNIT 3 ¿ SMALL BLACK SPECK INSIDE THE SEALED ON THE FILM AND APPROXIMATELY .07 SQUARE MILLIMETERS. UNIT 4 ¿ BLACK SPECK ON THE NEEDLE COVER AND A LOOSE FIBER INSIDE OF THE SEALED ON THE FILM AND APPROXIMATELY 1.50 SQUARE MILLIMETERS. UNIT 5 ¿ SMALL BLACK SPECK INSIDE OF THE SEALED PACKAGE AND APPROXIMATELY .07 SQUARE MILLIMETERS. UNIT 6 ¿ SMALL BLACK SPECKS ON THE BARREL AND SEALED BETWEEN THE TOP AND BOTTOM WEBS AND APPROXIMATELY .07 AND .06 SQUARE MILLIMETERS. UNIT 7 ¿ SMALL BLACK SPECKS SEALED BETWEEN THE TOP AND BOTTOM WEBS AND BETWEEN .15 AND .06 SQUARE MILLIMETERS. CONCLUSION(S): PACKAGING PROCESS ¿ THE DEFECT FOREIGN MATTER WAS CONFIRMED WITH SEVEN OF THE RETURNED UNITS. THE UNITS WERE SENT FTIR TEST TO IDENTIFY THE FOREIGN MATTER. PER THE FTIR TESTING THE FM WAS IDENTIFIED AS POLYACETAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER FOREIGN MATTER WAS MIXED IN THREE CATHETERS. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: FM GOT MIXED.

    Additional Manufacturer Narrative · 1

    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 BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER FOREIGN MATTER WAS MIXED IN THREE CATHETERS. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: FM GOT MIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715835 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9002870 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other