BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC WING PNK 20GA X 1.0IN

    MDR report key: 10925687 · Received December 1, 2020

    Report

    Report Number
    1710034-2020-00769
    Event Type
    Malfunction
    Date Received
    December 1, 2020
    Date of Event
    November 4, 2020
    Report Date
    December 28, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903826330
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED TWO UNOPENED UNITS FROM LOT 9331221, TWENTY-FOUR UNOPENED UNITS FROM LOT 0164704, ONE UNOPENED UNIT FROM LOT 0119482, FOUR UNOPENED UNITS FROM LOT 0196769, TWO UNOPENED UNITS FROM LOT 0210337, AND TWO UNOPENED UNITS FROM LOT 0111292. THE UNITS WERE INSPECTED FOR SUFFICIENT COLORING BY COMPARING THE LUER END OF EACH PART TO A COLOR CHIP TO ASSURE COLOR WAS WITHIN NOMINAL RANGE. BOTH UNITS FROM LOT 9331221 WERE WITHIN SPECIFICATION, TWENTY-ONE UNITS FROM LOT 0164704 WERE FOUND TO BE OUTSIDE SPECIFICATION, UNIT FROM LOT 0119482 WAS FOUND TO BE OUTSIDE OF SPECIFICATION, ALL UNITS FROM LOT 0196769 WERE FOUND TO BE OUTSIDE OF SPECIFICATION, BOTH UNITS FROM LOT 0210337 WERE WITHIN SPECIFICATION, AND BOTH UNITS FROM LOT 0111292 WERE FOUND TO BE OUTSIDE SPECIFICATION. TWENTY-EIGHT OF THE THIRTY-FIVE RETURNED UNITS WERE FOUND TO BE OUTSIDE OF THE COLOR SPECIFICATION, CONFIRMING THE REPORTED ISSUE. BEFORE STARTUP OF THE MANUFACTURING PROCESS, THE COLOR FEEDER IS CLEARED AND THE NEW COLOR IS ADDED. DUE TO THE SLIGHT COLOR OF THE UNITS, THE MOST PROBABLE CAUSE IS AN ERROR DURING THE COLOR CHANGE OVER PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSYTE AUTOG BC WING PNK 20GA X 1.0IN WAS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382633 BATCH NO.: 9331221, 0164704, 0119482, 0196769, 0210337, 0111292 IT WAS REPORTED THAT THE COLOR IS PALE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT # 9337157. THIS DOES NOT MATCH THE CATALOG NUMBER PROVIDED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9331221. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30, DEVICE MANUFACTURE DATE: 2019-11-27. MEDICAL DEVICE LOT #: 0164704 MEDICAL DEVICE EXPIRATION DATE: 2023-05-31 DEVICE MANUFACTURE DATE: 2020-06-12. MEDICAL DEVICE LOT #: 0119482 MEDICAL DEVICE EXPIRATION DATE: 2023-04-30 DEVICE MANUFACTURE DATE: 2020-05-01. MEDICAL DEVICE LOT #: 0196769 MEDICAL DEVICE EXPIRATION DATE: 2023-06-30 DEVICE MANUFACTURE DATE: 2020-07-14. MEDICAL DEVICE LOT #: 0210337 MEDICAL DEVICE EXPIRATION DATE: 2023-07-31 DEVICE MANUFACTURE DATE: 2020-07-28. MEDICAL DEVICE LOT #: 0111292 MEDICAL DEVICE EXPIRATION DATE: 2023-03-31 DEVICE MANUFACTURE DATE: 2020-04-23. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSYTE AUTOG BC WING PNK 20GA X 1.0IN WAS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382633 BATCH NO.: 9331221, 0164704, 0119482, 0196769, 0210337, 0111292. IT WAS REPORTED THAT THE COLOR IS PALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1394789 INSYTE AUTOG BC WING PNK 20GA X 1.0IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382633 SEE H.10 30382903826330

    Patients

    Seq Age Sex Outcome Treatment
    1