BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 60ML LL BRAZIL

    MDR report key: 10242675 · Received July 7, 2020

    Report

    Report Number
    1911916-2020-00626
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    June 17, 2020
    Report Date
    July 21, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY NO SAMPLE OR PHOTO WAS PROVIDED FOR INVESTIGATION. THEREFORE, NO SAMPLE/PHOTO ANALYSIS COULD BE PERFORMED, AND THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBERS 9182626, 9182627, AND 8332963 THIS IS THE 1ST COMPLAINT FOR THIS TYPE OF DEFECT OR SYMPTOM. BASED ON THE VERBATIM IT SEEMS THERE IS A DISCREPANCY OF THE PACKING SLIP AND THE INVOICE; THIS MANUFACTURING SITE DOESN¿T SUPPLY PRODUCTS TO CUSTOMERS; IT IS RECOMMENDED THAT MARKETING CONTACTS THE DISTRIBUTION CENTER THAT SUPPLIED THE PRODUCTS TO THIS CUSTOMER TO FIX THE DOCUMENTATION ISSUE.

    Additional Manufacturer Narrative · 0

    CORRECTION: INFORMATION WAS RECEIVED ABOUT THIS COMPLAINT. WE WERE INFORMED THAT WHEN CONTACTING THE CUSTOMER THERE WERE NO DIVERGENCES, HE JUST NEEDED THE EXPIRATION DATE INFORMATION. SO THIS ISSUE WAS RESOLVED AT THE DISTRIBUTION CENTER. THUS THIS COMPLAINT IS BEING CANCELED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 60ML LL BRAZIL HAD INCORRECT LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE RECEIVING NF 549.238 AND WE DETECTED A DIVERGENCE IN LOTS 9182626 AND 9182627 OF ITEM 302827, THE SAME HAS A VALIDITY IN THE PHYSICAL AND IN THE NF THERE IS ANOTHER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 60ML LL BRAZIL HAD INCORRECT LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE RECEIVING NF 549.238 AND WE DETECTED A DIVERGENCE IN LOTS 9182626 AND 9182627 OF ITEM 302827, THE SAME HAS A VALIDITY IN THE PHYSICAL AND IN THE NF THERE IS ANOTHER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9182626, MEDICAL DEVICE EXPIRATION DATE: 2024-06-30, DEVICE MANUFACTURE DATE: 2019-07-01, MEDICAL DEVICE LOT #: 9182627, MEDICAL DEVICE EXPIRATION DATE: 2024-06-30, DEVICE MANUFACTURE DATE: 2019-07-01. 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 SYRINGE 60ML LL BRAZIL HAD INCORRECT LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE RECEIVING NF 549.238 AND WE DETECTED A DIVERGENCE IN LOTS 9182626 AND 9182627 OF ITEM 302827, THE SAME HAS A VALIDITY IN THE PHYSICAL AND IN THE NF THERE IS ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707070 SYRINGE 60ML LL BRAZIL SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other