BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 16053105 · Received December 27, 2022

    Report

    Report Number
    1911916-2022-00777
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    December 7, 2022
    Report Date
    February 8, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE HAD AN EXTRA AMOUNT OF LIQUID ASPIRATED, LIKE A SMALL DROP OF DRUG, OUTSIDE THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: AT CHEMOTHERAPY OUTPATIENT FACILITY, THE PHARMACIST THAT HANDLES THE DRUGS REPORTED THAT DURING ASPIRATION WITH 50ML SYRINGE (PICTURE ATTACHED), SHE NOTICES THAT THERE IS AN EXTRA AMOUNT OF LIQUID ASPIRATED, LIKE A SMALL DROP OF DRUG, OUTSIDE THE SYRINGE. "THE RUBBER IS SOMETIMES ALREADY CROOKED OR WHEN WE HANDLE IT, MAYBE DUE TO THE PRESSURE IT BENDS A LITTLE, WE NOTICE THE LEAK CAN OCCUR FOR THIS REASON." H6: INVESTIGATION SUMMARY IT WAS REPORTED THERE IS AN EXTRA AMOUNT OF LIQUID ASPIRATED, LIKE A SMALL DROP OF DRUG, OUTSIDE THE SYRINGE WHEN DRAWING UP MEDICATION. TO AID IN THE INVESTIGATION, FOUR PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS A PACKAGING BLISTER TOP WEB. THE OTHER THREE PHOTOS SHOW A SYRINGE UPSIDE DOWN. THE SYRINGE HAS 50ML OF A SOLUTION. BETWEEN THE STOPPER RIBS APPEARS TO BE DROPLETS OF SOLUTION. HOWEVER, IT IS NOT CLEAR IN THE PHOTOS IF IT IS SOLUTION OR A REFLECTION OF LIGHT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303552, LOT 2210359. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED, AND WITHOUT THE PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Additional Manufacturer Narrative · 0

    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 BD PLASTIPAK¿ SYRINGE HAD AN EXTRA AMOUNT OF LIQUID ASPIRATED, LIKE A SMALL DROP OF DRUG, OUTSIDE THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: AT CHEMOTHERAPY OUTPATIENT FACILITY, THE PHARMACIST THAT HANDLES THE DRUGS REPORTED THAT DURING ASPIRATION WITH 50ML SYRINGE (PICTURE ATTACHED), SHE NOTICES THAT THERE IS AN EXTRA AMOUNT OF LIQUID ASPIRATED, LIKE A SMALL DROP OF DRUG, OUTSIDE THE SYRINGE. "THE RUBBER IS SOMETIMES ALREADY CROOKED OR WHEN WE HANDLE IT, MAYBE DUE TO THE PRESSURE IT BENDS A LITTLE, WE NOTICE THE LEAK CAN OCCUR FOR THIS REASON."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE HAD AN EXTRA AMOUNT OF LIQUID ASPIRATED, LIKE A SMALL DROP OF DRUG, OUTSIDE THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: AT CHEMOTHERAPY OUTPATIENT FACILITY, THE PHARMACIST THAT HANDLES THE DRUGS REPORTED THAT DURING ASPIRATION WITH 50ML SYRINGE (PICTURE ATTACHED), SHE NOTICES THAT THERE IS AN EXTRA AMOUNT OF LIQUID ASPIRATED, LIKE A SMALL DROP OF DRUG, OUTSIDE THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2585298 BD PLASTIPAK¿ SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2210359

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown