BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WINGSET SEZSET 27X.38 12 W/O LUER

    MDR report key: 12610833 · Received October 11, 2021

    Report

    Report Number
    9610048-2021-00136
    Event Type
    Malfunction
    Date Received
    October 11, 2021
    Date of Event
    September 13, 2021
    Report Date
    October 27, 2021
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 8180614, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED THAT THE HUB WAS CRACKED OR DAMAGED. BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, WITHOUT A PHYSICAL SAMPLE AVAILABLE FOR INSPECTION THE ENGINEER COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE FOR THE OBSERVED DAMAGE.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT WINGSET SEZSET 27X.38 12 W/O LUER WAS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEVICE PRESENTS CRACK WHEN CONNECTING TO SYRINGE. CUSTOMER PROVIDED TO US THE ADDITIONAL INFORMATION: WAS THERE ANY HARM TO THE PATIENT/HEALTHCARE PROFESSIONAL? (DETAIL) TO THE PATIENT THERE WAS NO HARM. TO THE PROFESSIONAL THERE WAS CONTAMINATION OF THE GLOVE WITH RADIOACTIVE MATERIAL. WAS THERE A DRUG LEAK DUE TO THE DIVERSION? THERE WAS, CAUSING CONTAMINATION OF THE EXAMINATION ROOM, WHERE IT HAD TO BE DISUSED FOR 1 DAY. WAS THERE ANY EXPOSURE OF BLOOD OR CHEMOTHERAPY TO MUCOUS MEMBRANES OR SKIN? (DETAIL) NOT. WHAT MEDICATION WAS BEING ADMINISTERED? THE DRUG THAT WAS BEING USED WAS A RADIOPHARMACEUTICAL, A COMBINATION OF MDP WITH TECHNETIUM, A RADIOACTIVE SUBSTANCE USED TO PERFORM BONE SCINTIGRAPHY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WINGSET SEZSET 27X.38 12 W/O LUER WAS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEVICE PRESENTS CRACK WHEN CONNECTING TO SYRINGE. CUSTOMER PROVIDED TO US THE ADDITIONAL INFORMATION: WAS THERE ANY HARM TO THE PATIENT/HEALTHCARE PROFESSIONAL? (DETAIL). TO THE PATIENT THERE WAS NO HARM. TO THE PROFESSIONAL THERE WAS CONTAMINATION OF THE GLOVE WITH RADIOACTIVE MATERIAL. WAS THERE A DRUG LEAK DUE TO THE DIVERSION? THERE WAS, CAUSING CONTAMINATION OF THE EXAMINATION ROOM, WHERE IT HAD TO BE DISUSED FOR 1 DAY. WAS THERE ANY EXPOSURE OF BLOOD OR CHEMOTHERAPY TO MUCOUS MEMBRANES OR SKIN? (DETAIL) NOT. WHAT MEDICATION WAS BEING ADMINISTERED? THE DRUG THAT WAS BEING USED WAS A RADIOPHARMACEUTICAL, A COMBINATION OF MDP WITH TECHNETIUM, A RADIOACTIVE SUBSTANCE USED TO PERFORM BONE SCINTIGRAPHY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WINGSET SEZSET 27X.38 12 W/O LUER WAS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEVICE PRESENTS CRACK WHEN CONNECTING TO SYRINGE. CUSTOMER PROVIDED TO US THE ADDITIONAL INFORMATION: WAS THERE ANY HARM TO THE PATIENT/HEALTHCARE PROFESSIONAL? (DETAIL) TO THE PATIENT THERE WAS NO HARM. TO THE PROFESSIONAL THERE WAS CONTAMINATION OF THE GLOVE WITH RADIOACTIVE MATERIAL. WAS THERE A DRUG LEAK DUE TO THE DIVERSION? THERE WAS, CAUSING CONTAMINATION OF THE EXAMINATION ROOM, WHERE IT HAD TO BE DISUSED FOR 1 DAY. WAS THERE ANY EXPOSURE OF BLOOD OR CHEMOTHERAPY TO MUCOUS MEMBRANES OR SKIN? (DETAIL) NOT. WHAT MEDICATION WAS BEING ADMINISTERED? THE DRUG THAT WAS BEING USED WAS A RADIOPHARMACEUTICAL, A COMBINATION OF MDP WITH TECHNETIUM, A RADIOACTIVE SUBSTANCE USED TO PERFORM BONE SCINTIGRAPHY.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FIRST NAME: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WINGSET SEZSET 27X.38 12 W/O LUER WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEVICE PRESENTS CRACK WHEN CONNECTING TO SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504378 WINGSET SEZSET 27X.38 12 W/O LUER CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 8180614

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown