BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 13122586 · Received December 30, 2021

    Report

    Report Number
    3003916417-2021-00380
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    December 2, 2021
    Report Date
    January 21, 2022
    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

    H.6. INVESTIGATION: PHOTOS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, IT IS POSSIBLE TO OBSERVE THAT THE FOREIGN MATTER IN THE CANNULA RESEMBLES ACCUMULATED SILICONE, WHICH INDICATES THAT THE CONTAMINATION HAPPENED AFTER THE ASSEMBLY STAGE. THE ANALYSIS OF THE BATCH HISTORY WAS PERFORMED, QUALITY NOTIFICATIONS WERE VERIFIED, AND NO RECORDS WERE FOUND THAT WERE POTENTIALLY RELATED TO THE INCIDENT. MAINTENANCE ORDER NUMBER 603472260 WAS OBSERVED, WITH THREADED WASHERS AT THE LUBE OUTLET AND MAINTENANCE OCCURRENCES POTENTIALLY RELATED TO THE INCIDENT. BY ANALYZING THE PHOTOS, IT IS POSSIBLE TO OBSERVE THAT THE FOREIGN MATTER RESEMBLES ACCUMULATED SILICONE, WHICH INDICATES THAT THE CONTAMINATION HAPPENED AFTER THE ASSEMBLY STAGE. THE POSSIBLE CAUSE OF THE INCIDENT WAS THE SCREWING OF THE HARNESS AFTER THE SILICONIZING STATION, CAUSING CONTAMINATION TO THE PRODUCT. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    (B)(6). 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 APPEARED TO HAVE RUST ON THE NEEDLE. THIS EVENT OCCURRED 3 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "5ML SYRINGE WITH NEEDLE (990628) WITH "RUSTY" APPEARANCE. NOTICED WHEN OPENING THE PACKAGE, DURING. NO DAMAGE, DID NOT APPLY.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE APPEARED TO HAVE RUST ON THE NEEDLE. THIS EVENT OCCURRED 3 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "5ML SYRINGE WITH NEEDLE (990628) WITH "RUSTY" APPEARANCE. NOTICED WHEN OPENING THE PACKAGE, DURING. NO DAMAGE, DID NOT APPLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021436 BD PLASTIPAK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 1132397

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown