BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ STERILE PLASTIC SYRINGE

    MDR report key: 17548595 · Received August 15, 2023

    Report

    Report Number
    3003916417-2023-00223
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    August 1, 2023
    Report Date
    October 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
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SAMPLE AND PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT THE STOPPER WAS INCORRECTLY ASSEMBLED TO THE PLUNGER, DISTORTED AGAINST THE BARREL WALL. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2348792, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THIS ISSUE WAS DETERMINED TO HAVE OCCURRED AS A RESULT OF IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER TO THE BARREL DURING ASSEMBLY. ADJUSTMENTS/ALIGNMENTS WERE MADE.

    Additional Manufacturer Narrative · 0

    H3. 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

    ADDITIONAL INFORMATION RECEIVED. SYRINGE WITH PISTON CROCKED. CUSTOMER PROVIDED TO US THE ADDITIONAL INFORMATION BELOW. WAS THE REPORTED INCIDENT NOTICED BEFORE, DURING OR AFTER USE? BEFORE USING. WAS THERE ANY HARM TO THE PATIENT/CAREGIVER? (DETAIL) NO. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO THE INCIDENT (IMAGING TESTS, SURGERY, MEDICATION ADMINISTRATION, ETC.)? (DETAIL) NO. WAS THERE EXPOSURE TO BLOOD OR CHEMOTHERAPY TO MUCOUS MEMBRANES OR SKIN? (DETAIL) NO. WHAT MEDICATION WAS BEING ADMINISTERED? NO MEDICINE WAS USED. IS THE SAMPLE RELATED TO THE INCIDENT AVAILABLE FOR ANALYSIS? IF SO, HOW MANY UNITS? (WE COLLECT A MAXIMUM OF 10 UNITS FOR ANALYSIS PURPOSES). 1 SAMPLE SENT FOR STANDARDIZATION. COMPANY NAME: (B)(6). CNPJ: 56.577.059/00006-06. ICMS TAXPAYER (YES/NO): NO. IF YOU ARE A TAXPAYER, DO YOU ISSUE AN INVOICE? (YES/NO): WE ARE NOT TAXPAYERS. PRODUCT PURCHASE INVOICE NUMBER: (B)(4). FULL ADDRESS (SECTOR/DEPARTMENT): (B)(6). IS THE SAMPLE CONTAMINATED? IF YES, WHAT SUBSTANCE? NO. HOW MANY UNITS ARE AVAILABLE FOR COLLECTION? 01 UNIT. CONTACT (NAME AND PHONE): (B)(6). WAS THERE A NOTIFICATION TO ANVISA? IF SO, WHAT IS THE NOTIFICATION NUMBER? YES, (B)(4). EVENT OCCURRENCE DATE UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ STERILE PLASTIC SYRINGE STOPPER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: SYRINGE WITH PISTON CROOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1707421 BD PLASTIPAK¿ STERILE PLASTIC SYRINGE PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 2348792

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown