BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE PLASTIPAK 10ML S/SU

    MDR report key: 22286344 · Received June 18, 2025

    Report

    Report Number
    3003916417-2025-00115
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    May 26, 2025
    Report Date
    July 3, 2025
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    UDI-DI
    07891463000378
    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

    A BATCH HISTORY ANALYSIS (DHR) WAS CARRIED OUT, MAINTENANCE RECORDS AND QUALITY NOTIFICATIONS WERE CHECKED, AND NO RECORDS POTENTIALLY RELATED TO THIS DEFECT WERE FOUND FOR THIS BATCH. USING THE PHOTO PROVIDED, IT IS POSSIBLE TO VERIFY THE FAILURE IN THE POSITIONING OF THE STOPPER, WHICH MAY OCCUR DURING THE SYRINGE ASSEMBLY PROCESS DUE TO SOME MISALIGNMENT OF COMPONENTS, THEN BD CONFIRMS/REPRODUCES THE COMPLAINT. WE INFORM YOU THAT THE CURRENT CONTROLS TO DETECT THE INCIDENT ARE CARRIED OUT THROUGH VISUAL INSPECTION EVERY HOUR IN THE MATERIAL CYCLE IN THE PACKAGING PROCESS AND THIS RISK IS COVERED IN FMEA, IN ACCORDANCE WITH THE PRODUCT SPECIFICATION. WE ALSO INFORM YOU THAT THIS TYPE OF DEFECT ONLY AFFECTS THE APPEARANCE OF THE COMPONENT, AS THE EQUIPMENT AUTOMATICALLY REJECTS PARTS THAT DO NOT REACH THE TIGHTNESS LIMITS, REDUCING DAMAGE TO THIRD PARTIES IN CASE OF USE. AS THIS IS THE FIRST COMPLAINT FOR THE BATCH, NOT EXCEEDING THE NOTIFICATION OF ACCEPTABLE QUALITY (AQL) THRESHOLD, THE INCIDENT IDENTIFIED FROM THIS COMPLAINT WILL BE MONITORED FOR TREND ASSESSMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE PLASTIPAK 10ML 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 ANVISA BEEN NOTIFIED? IF SO, WHAT WAS THE NOTIFICATION NUMBER? WAS ANVISA 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 INFORMAITON REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497465 BD SYRINGE PLASTIPAK 10ML S/SU PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 5058883 07891463000378

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown