BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCALP 25G

    MDR report key: 8735937 · Received June 26, 2019

    Report

    Report Number
    9610048-2019-00212
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    June 4, 2019
    Report Date
    July 5, 2019
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00038290388339
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ACCORDING TO THE VISUAL ANALYSIS OF THE SAMPLE PHOTO IT CAN BE OBSERVED THAT THE TUBE HAS BEEN RELEASED FROM THE CANNON. THE ROOT CAUSE FOR THE DEFECT OCCURRED WAS A POTENTIAL FAILURE OF THE ZUMBACK PIECE OF EQUIPMENT THAT CONTROLS THE INTERNAL, EXTERNAL DIAMETER AND WALL OF THE EXTRUDED TUBE GENERATING PIPE OUT OF SPECIFICATION (THINNER TUBE) DUE TO THE THINNER TUBE MAY HAVE BROKEN OUT TO GENERATE THE REPORTED DEFECT. THIS LOT WAS REVIEWED REGARDING "TRACTION PIPE X CANNON" AND "DAMAGED COMPONENT¿ AND WAS EVIDENCED QUALITY NOTIFICATION (B)(4) OF LOW TRACTION TUBE X CANNON WHICH MAY BE RELATED TO THE REPORTED DEFECT. A CORRECTIVE ACTION PROJECT, CAPA#873458, HAS BEEN INITIATED TO INVESTIGATE THE ISSUE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE SCALP 25G WHILE INJECTING THE TUBE RUPTURED AND SPILLAGE OF THE RADIOACTIVE MATERIAL. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: WHEN INJECTING RADIOACTIVE MATERIAL BY PERIPHERAL VENOUS ACCESS IN A PATIENT IN NUCLEAR MEDICINE, THERE WAS RUPTURE OF THE SCALP AND SPILLAGE OF THE RADIOACTIVE MATERIAL IN THE COLLABORATOR WHO PERFORMED THE PROCEDURE AND ON THE FLOOR OF THE SECTOR. THERE WAS NO DAMAGE TO THE PATIENT/HEALTH PROFESSIONAL. THERE WAS NO NEED FOR MEDICAL OR SURGICAL INTERVENTION. AFTER THE INCIDENT, THE EXAM WAS DONE NORMALLY. THERE WAS NO NEED FOR PROPHYLACTIC MEDICAMENTATION TO THE CONTRIBUTOR. THERE WAS NO EXPOSURE OF THE DRUG TO THE SKIN. THE PROFESSIONAL WAS USING THE INSTITUTIONAL UNIFORM AND GLOVES. THE DRUG THAT WAS BEING ADMINISTRATED WAS SALINE.

    Additional Manufacturer Narrative · 1

    (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE SCALP 25G WHILE INJECTING THE TUBE RUPTURED AND SPILLAGE OF THE RADIOACTIVE MATERIAL. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN INJECTING RADIOACTIVE MATERIAL BY PERIPHERAL VENOUS ACCESS IN A PATIENT IN NUCLEAR MEDICINE, THERE WAS RUPTURE OF THE SCALP AND SPILLAGE OF THE RADIOACTIVE MATERIAL IN THE COLLABORATOR WHO PERFORMED THE PROCEDURE AND ON THE FLOOR OF THE SECTOR. THERE WAS NO DAMAGE TO THE PATIENT/HEALTH PROFESSIONAL. THERE WAS NO NEED FOR MEDICAL OR SURGICAL INTERVENTION. AFTER THE INCIDENT, THE EXAM WAS DONE NORMALLY. THERE WAS NO NEED FOR PROPHYLACTIC MEDICAMENTATION TO THE CONTRIBUTOR. THERE WAS NO EXPOSURE OF THE DRUG TO THE SKIN. THE PROFESSIONAL WAS USING THE INSTITUTIONAL UNIFORM AND GLOVES. THE DRUG THAT WAS BEING ADMINISTRATED WAS SALINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531360 SCALP 25G CATHETER SOLUTIONS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 8067798 00038290388339

    Patients

    Seq Age Sex Outcome Treatment
    1 Other