BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I125 SEEDS IN QUICKLINK CARTRIDGE (IN PEWTER TRAY), STERILE, CE MARKED

    MDR report key: 6215684 · Received December 30, 2016

    Report

    Report Number
    1018233-2016-01906
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Date of Event
    December 9, 2016
    Report Date
    March 22, 2017
    Manufacturer
    BARD BRACHYTHERAPY, INC. -1424526
    Product Code
    KXK
    PMA / PMN Number
    K043246
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PHYSICAL SAMPLE WAS RECEIVED FOR EVALUATION; HOWEVER, PICTURES WERE PROVIDED BY THE CUSTOMER THAT INDICATED THAT THE PRODUCT FROM SALES ORDER (B)(4) WAS SHIPPED WITH THE DOCUMENTATION AND OUTER BOX FOR SALES ORDER (B)(4). THE LABELING AFFIXED TO THE PEWTER TRAY AND QUICKLINK BOX INDICATED THE SALES ORDER WAS (B)(4) AND NOT (B)(4), AS INDICATED ON THE SHIPPING BOX AS WELL AS ACCOMPANYING CERTIFICATES AND DOCUMENTATION. THIS COMPLAINT WAS CONFIRMED AS A MANUFACTURING RELATED ISSUE. (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED TO BARD BRACHYTHERAPY INC FOR EVALUATION; HOWEVER; PICTURES WERE PROVIDED. THE COMPLAINT WAS CONFIRMED AS A MANUFACTURING RELATED ISSUE. THE PICTURES INDICATE THAT THE PRODUCT FROM SALES ORDER (B)(4) WAS SHIPPED WITH THE DOCUMENTATION AND OUTER BOX FOR SALES ORDER (B)(4). THE CUSTOMER ORDER RELEASE PAPERWORK FOR SALES ORDER (B)(4) WAS RETRIEVED AND REVIEWED. ALL DOCUMENTATION INDICATED THAT THE ORDER WAS FILLED CORRECTLY BY THE STERILE PRODUCTS LAB ON (B)(6) 2016. THE ORDER WAS THEN CHECKED BY QA AND RELEASED FOR STERILIZATION PROCESSING ON THE SAME DAY. UPON RETURN FROM STERILIZATION THE NEXT DAY, THIS ORDER WAS VERIFIED, PACKED, AND SHIPPED TO THE CUSTOMER. DURING THE VERIFICATION PROCESS, ALL ORDER COMPONENTS INDICATED ON THE PICKING LIST ARE VERIFIED TO BE PRESENT AND VERIFIED TO BE PLACED INTO THE CORRECT SHIPPING BOX(ES). DURING THE PACKING PROCESS, ALL ORDER COMPONENTS FOR EACH ORDER ARE PLACED INTO THE APPROPRIATE BOX(ES). EVEN THOUGH THESE STEPS WERE PERFORMED AND DOCUMENTED AS SUCH, IT IS POSSIBLE THAT THE QUICKLINK TRAYS WERE INADVERTENTLY SWITCHED FOR SALES ORDERS (B)(4). THESE NUMBERS ARE VERY SIMILAR, AND DURING AN INTERVIEW WITH THE VERIFIER FOR THESE ORDERS, IT IS POSSIBLE THAT THE NUMBERS WERE TRANSPOSED. EVEN THOUGH THE LABELING DISPLAYED THE INCORRECT SALES ORDER NUMBER, THE LABELING WAS FOUND TO BE ADEQUATE AS THE CUSTOMER IDENTIFIED THE DISCREPANCY PRIOR TO THE PATIENT IMPLANT. (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. CORRECTIONS: DEVICE AVAILABLE FOR EVALUATION?, DEVICE EVALUATED BY MFR? AND EVALUATION CODES. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTER BOX OF SEEDS WAS OPENED (TRN155), AND THE METAL BOX INSIDE WAS FOUND TO HAVE A DIFFERENT CASE ID OF GEO733EG. THE CORRECT CASE NEEDED WAS TRN155. CASE TRN155 SHOULD HAVE CONTAINED 80 SEEDS; HOWEVER, THE INNER CASE WITH ID (B)(4) ONLY CONTAINED 54 SEEDS WITH A 20% HIGHER ACTIVITY THAN WHAT WAS ORDERED. THE UROLOGIST DECIDED TO START AND COMPLETE THE PROCEDURE WITH THE INCORRECT ACTIVITY SEEDS AS HE ADJUSTED THE NUMBER OF SEEDS NEEDED FOR THE PROCEDURE. THE PATIENT ALLEGEDLY RECEIVED THE CORRECT ACTIVITY NEEDED. THE UROLOGIST STATED THAT THE IMPLANTS SHOULD NOT CAUSE ANY NEGATIVE SIDE EFFECTS OR HARM TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTER BOX OF SEEDS WAS OPENED (TRN155), AND THE METAL BOX INSIDE WAS FOUND TO HAVE A DIFFERENT CASE ID OF GEO733EG. THE CORRECT CASE NEEDED WAS TRN155. CASE TRN155 SHOULD HAVE CONTAINED 80 SEEDS; HOWEVER, THE INNER CASE WITH ID GEO733EG ONLY CONTAINED 54 SEEDS WITH A 20% HIGHER ACTIVITY THAN WHAT WAS ORDERED. THE UROLOGIST DECIDED TO START AND COMPLETE THE PROCEDURE WITH THE INCORRECT ACTIVITY SEEDS AS HE ADJUSTED THE NUMBER OF SEEDS NEEDED FOR THE PROCEDURE. THE PATIENT ALLEGEDLY RECEIVED THE CORRECT ACTIVITY NEEDED. THE UROLOGIST STATED THAT THE IMPLANTS SHOULD NOT CAUSE ANY NEGATIVE SIDE EFFECTS OR HARM TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTER BOX OF SEEDS WAS OPENED (TRN155) AND THE METAL BOX WAS FOUND TO HAVE A DIFFERENT CASE ID OF (B)(4). THE CORRECT CASE NEEDED FOR THIS PRODUCT WAS TRN155. CASE TRN155 SHOULD HAVE CONTAINED (B)(4) SEEDS; HOWEVER, THE INNER CASE WITH ID (B)(4) ONLY CONTAINED (B)(4) SEEDS WITH A 20% HIGHER ACTIVITY THAN WHAT WAS ORDERED. THE UROLOGIST DECIDED TO START AND COMPLETE THE PROCEDURE WITH THE INCORRECT ACTIVITY SEEDS AS HE ADJUSTED THE NUMBER OF SEEDS NEEDED FOR THE PROCEDURE. THE PATIENT RECEIVED THE CORRECT ACTIVITY NEEDED. THE UROLOGIST WAS CONVINCED THIS WOULD NOT HAVE CAUSED ANY NEGATIVE SIDE EFFECTS OR HARM TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTER BOX OF SEEDS WAS OPENED (TRN155), AND THE METAL BOX INSIDE WAS FOUND TO HAVE A DIFFERENT CASE ID OF (B)(4). THE CORRECT CASE NEEDED WAS TRN155. CASE TRN155 SHOULD HAVE CONTAINED 80 SEEDS; HOWEVER, THE INNER CASE WITH ID (B)(4) ONLY CONTAINED 54 SEEDS WITH A 20% HIGHER ACTIVITY THAN WHAT WAS ORDERED. THE UROLOGIST DECIDED TO START AND COMPLETE THE PROCEDURE WITH THE INCORRECT ACTIVITY SEEDS AS HE ADJUSTED THE NUMBER OF SEEDS NEEDED FOR THE PROCEDURE. THE PATIENT ALLEGEDLY RECEIVED THE CORRECT ACTIVITY NEEDED. THE UROLOGIST STATED THAT THE IMPLANTS SHOULD NOT CAUSE ANY NEGATIVE SIDE EFFECTS OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864974 I125 SEEDS IN QUICKLINK CARTRIDGE (IN PEWTER TRAY), STERILE, CE MARKED QUICKLINK CARTRIDGE 125CE KXK BARD BRACHYTHERAPY, INC. -1424526 TRN155 (328784)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention