BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SOLOMED¿ SYRINGE

    MDR report key: 17507383 · Received August 11, 2023

    Report

    Report Number
    3003916417-2023-00215
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 26, 2023
    Report Date
    August 31, 2023
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    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 SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2073245. D.4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2027. H.4. DEVICE MANUFACTURE DATE: 14-MAR-2022. D.4. MEDICAL DEVICE LOT #: 2073242. D.4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2027. H.4. DEVICE MANUFACTURE DATE: 14-MAR-2022. D.4. MEDICAL DEVICE LOT #: 2077110. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027. H.4. DEVICE MANUFACTURE DATE: 18-MAR-2022. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER SEPARATED FROM THE BD SOLOMED¿ SYRINGE WHILE ASPIRATING MEDICINE. IT WAS UNSPECIFIED WHETHER THE EVENT TOOK PLACE WITH LOT 2073245, 2073242 OR 2077110. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "CUSTOMER HAS RECEIVED COMPLAINTS AFTER MARKET IN WHICH THE END USERS REPORT THE SYRINGE THAT GOES INSIDE THE DRUG PACK WAS DEFECTIVE IN ITS PLUNGER. IN FIRST OCCURRENCE, THE USER REPORTS THE PLUNGER IS JAMMED, RIGID, SO IT WAS NOT ABLE TO ASPIRATE THE MEDICATION; IN THE OTHER TWO OCCURRENCES, THE USER REPORT THAT WHEN THE MEDICATION WAS BEING ASPIRATED THE PLUNGER DETACHED. THE COMPANY ALSO REPORTS THAT THE SYRINGES ARE RECEIVED SEALED AND ARE MANUALLY STORED INSIDE THE CARTONS, SO THE ODDS OF THE ISSUE HAPPENING INSIDE THEIR COMPANY (DURING PRODUCTION) ARE LOW, SINCE THERE ARE NO STEPS IN THEIR PROCESS THAT WOULD COMPROMISE THE INTEGRITY OF THE SYRINGES;... THE BATCHES AFFECTED IN EACH EVENT ARE UNKNOWN, BUT SYRINGES' BATCHES USED IN COMPANY PRODUCTION WERE: 2073245, 2073242 AND 2077110."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER SEPARATED FROM THE BD SOLOMED¿ SYRINGE WHILE ASPIRATING MEDICINE. IT WAS UNSPECIFIED WHETHER THE EVENT TOOK PLACE WITH LOT 2073245, 2073242 OR 2077110. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "CUSTOMER HAS RECEIVED COMPLAINTS AFTER MARKET IN WHICH THE END USERS REPORT THE SYRINGE THAT GOES INSIDE THE DRUG PACK WAS DEFECTIVE IN ITS PLUNGER. IN FIRST OCCURRENCE, THE USER REPORTS THE PLUNGER IS JAMMED, RIGID, SO IT WAS NOT ABLE TO ASPIRATE THE MEDICATION; IN THE OTHER TWO OCCURRENCES, THE USER REPORT THAT WHEN THE MEDICATION WAS BEING ASPIRATED THE PLUNGER DETACHED. THE COMPANY ALSO REPORTS THAT THE SYRINGES ARE RECEIVED SEALED AND ARE MANUALLY STORED INSIDE THE CARTONS, SO THE ODDS OF THE ISSUE HAPPENING INSIDE THEIR COMPANY (DURING PRODUCTION) ARE LOW, SINCE THERE ARE NO STEPS IN THEIR PROCESS THAT WOULD COMPROMISE THE INTEGRITY OF THE SYRINGES. THE BATCHES AFFECTED IN EACH EVENT ARE UNKNOWN, BUT SYRINGES' BATCHES USED IN COMPANY PRODUCTION WERE: 2073245, 2073242 AND 2077110.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355119 BD SOLOMED¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown