BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET BN306 W/O BP 200C

    MDR report key: 11952528 · Received June 7, 2021

    Report

    Report Number
    2243072-2021-01627
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 11, 2021
    Report Date
    June 16, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-05-15. INVESTIGATION SUMMARY: SBDM CONDUCTED VISUAL INSPECTION OF THE RECEIVED SAMPLE, FOUND TEAR ON THE IV SET TUBE. AS A RESULT OF OUR INVESTIGATION ACTIVITIES TO FIND THE ROOT CAUSE OF THE COMPLAINT SAMPLE, IT MAY BE CAUSED WHILE A TUBE EXTRUDING PROCESS. HOUSE SAMPLE INSPECTION: SBDM CHECKED 30 HOUSE SAMPLES OF THE COMPLAINT PRODUCT IV SET BN306 W/O BP 200C, LOT NO. 2103081, 2103311 & 2104091), STORED IN THE COMPANY, THERE WAS NO DEFECTIVE PRODUCT FOUND IN THEM. DHR REVIEW: SBDM REVIEW THE MANUFACTURING RECORD OF COMPLAINT SAMPLE, THERE IS NO ISSUE WHILE MANUFACTURING. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEW THE CUSTOMER COMPLAINT RECORD OF COMPLAINT SAMPLE, THERE IS NO SIMILAR ISSUE OF THE SAME PRODUCT FROM OTHER CUSTOMER. 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS UNKNOWN. SBDM CONDUCTED VISUAL INSPECTION OF THE RECEIVED SAMPLE, FOUND TEAR ON THE IV SET TUBE. SBDM FOUND TEAR ON THE RECEIVED IV SET TUBE AND IT SEEMED ROUGH AND NOT TO BE TEARED BY SHARP TOOL. SBDM TRIED TO FIND PLACE THAT SAME ISSUE IS OCCURRED IN THE EXTRUDING MACHINE (WATER VESSEL, TUBE MOVING BELT AND COILING DRUM). AND THERE IS CUTTING POINT ON THE COILING DRUM. ALSO, IT IS MANAGED NOT SHARPLY BUT, IT IS POSSIBLE THAT CUTTING POINT WAS DAMAGED ON THE ONE OF DRUM AND THE TUBE WAS CAUGHT IN THE SHARP POINT. THEREFORE, THE TUBE WAS DAMAGED. THE LIKELY CAUSE THAT IT IS POSSIBLE TO BE TORN THE IV SET TUBE WHILE THE TUBE WAS COILING ON THE DRUM. HOWEVER, THE IV SET ASSEMBLY LINE WORKER DID NOT FIND THE IV SET TUBE TORN AND IT CAUSED THIS COMPLAINT CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IV SET BN306 W/O BP 200C LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN CUSTOMER USE IV SET, THE FLUID WAS LEAKED ON THE TUBE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(6). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4)HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IV SET BN306 W/O BP 200C LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN CUSTOMER USE IV SET, THE FLUID WAS LEAKED ON THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847557 IV SET BN306 W/O BP 200C INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1