BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE PLASTIPAK 5ML S/SU

    MDR report key: 22287239 · Received June 18, 2025

    Report

    Report Number
    3003916417-2025-00116
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    May 26, 2025
    Report Date
    July 25, 2025
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    UDI-DI
    07891463001771
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE BATCH HISTORY (DHR) AND QUALITY NOTIFICATIONS WERE CHECKED, AND NO RECORDS RELATED TO THIS DEFECT WERE FOUND FOR THE BATCH OF PRESS USED. MAINTENANCE RECORDS WERE CHECKED, AND MAINTENANCE INCIDENTS POTENTIALLY RELATED TO THE INCIDENT WERE DETECTED. (B)(6) - END CUTTING. THROUGH THE PHOTOS PROVIDED, IT IS POSSIBLE TO VERIFY A FAILURE IN THE POSITIONING OF THE CORK, WHICH MAY BE DUE TO THE PRESS BEING FAULTY IN THE CROWN, THUS THE CORK NOT BEING FIXED. THEREFORE, BD CONFIRMS/REPRODUCES THE INQUIRY. THIS CAN BE PROVEN WITH THE CORRECTIVE MAINTENANCE ORDER THAT PERFORMED THE END CUTTING, WHICH MEANS THE MOLD WAS CLEANED, OBSTRUCTING THE MATERIAL FLOW, THUS CAUSING THE PRESS FAILURE. WE INFORM YOU THAT CURRENT CONTROLS FOR INCIDENT DETECTION ARE PERFORMED THROUGH VISUAL INSPECTION EVERY HOUR DURING THE MATERIAL CYCLE IN THE DELIVERY PROCESS, AND THIS RISK IS COVERED IN THE FMEA, BEING IN ACCORDANCE WITH THE PRODUCT FORECAST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE PLASTIPAK 5ML S/SU STOPPER WAS DEFECTIVE / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECENTLY RECEIVED SOME SPECIFIC TECHNICAL COMPLAINTS RELATED TO BD'S 5- AND 10-ML HYPODERMIC SYRINGES, HCPA CODE 2330, NF 835769. THE REPORTED PROBLEM REFERS TO THE PLUNGER COMING LOOSE AT THE MOMENT OF COLLECTION, AS ILLUSTRATED IN THE IMAGES BELOW. WE EMPHASIZE THAT THIS FAILURE DIRECTLY IMPACTS PATIENT CARE, SINCE, IN CASES LIKE THIS, IT IS NECESSARY TO PERFORM A NEW PUNCTURE TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 02 JUN 2025. IS THERE ANY IMPACT ON PATIENTS? IF SO, PLEASE EXPLAIN IN DETAIL. THE LOSS OF VACUUM AND THE DISPLACEMENT OF THE PLUNGER DURING THE BLOOD COLLECTION PROCEDURE AFFECT PATIENTS' CARE, AS THESE EVENTS OFTEN REQUIRE A SECOND PUNCTURE. THIS ADDITIONAL NEED CAN CAUSE DISCOMFORT AND PAIN FOR THE PATIENT, AS WELL AS POTENTIALLY INCREASING THE RISK OF COMPLICATIONS, SUCH AS TARGET LESIONS IN THE VENOUS NETWORK. IN ADDITION, SUCH OCCURRENCES HAVE AN IMPACT ON THE CONSUMPTION OF MATERIALS USED AND INCREASE THE TIME REQUIRED FOR CARE HAS (B)(4) BEEN NOTIFIED? IF SO, WHAT WAS THE NOTIFICATION NUMBER? WAS (B)(4) NOTIFIED? IF SO, WHAT WAS THE NOTIFICATION NUMBER? NO, BECAUSE IT WAS A ONE-OFF COMPLAINT. COULD YOU PROVIDE THE CATALOG NUMBER AND BATCH NUMBER? REF 990172, REF 990175, LOT 5058886, 5058883, 4299727 AND 4352281. CONFIRMATION OF QUANTITIES AFFECTED? IT WAS NOT POSSIBLE TO STORE AND ACCOUNT FOR THE MATERIAL BECAUSE IT WAS CONTAMINATED. CAN YOU CONFIRM THE DATE OF THE EVENT (DD/MMM/YYYY)? MAY 2025. IS THE SAMPLE RELATED TO THIS INCIDENT AVAILABLE FOR ANALYSIS? IF SO, IS THE SAMPLE RELATED TO THIS INCIDENT AVAILABLE FOR ANALYSIS? IF YES, PLEASE ANSWER THE FOLLOWING QUESTIONS NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787806 BD SYRINGE PLASTIPAK 5ML S/SU PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 4299727 07891463001771

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown