BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE

    MDR report key: 16117470 · Received January 6, 2023

    Report

    Report Number
    3002682307-2022-00364
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    December 17, 2022
    Report Date
    January 10, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY : A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306574 AND LOT NUMBER 2152611. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, SEVERAL SYRINGES WERE OBSERVED WITH BROKEN UNIT PACKAGING FILM NEAR THE PLUNGER AREA AND ONE SYRINGE WAS OBSERVED BROKEN. THE DEFECTIVE PACKAGING FILM RESULTED FROM THE SPIKES THAT PERFORATE THE FILM. IF THE PERFORATION IS NOT WELL ADJUSTED, THE PERFORATION BECOMES TOO LARGE WHICH CAN LEAD TO TEARING WHEN THE SYRINGES ARE PICKED UP AND PLACED WITHIN THE SHELF CARTONS. A PREVIOUS PROJECT WAS OPENED TO FURTHER INVESTIGATE THE SPIKES AND THE BROKEN PACKAGING FILM. ALL OF THE SPIKE POSITIONS HAVE BEEN CHECKED AND CORRECTED. THE DAMAGED SYRINGE MOST LIKELY RESULTED DUE TO A JAM DURING THE BARREL FEEDING AND PLUNGER ASSEMBLY PROCESS. IF A JAM OCCURS, THE OPERATOR MUST ENSURE THAT NO DAMAGED SYRINGES ARE PACKAGED. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE #: (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 POSIFLUSH¿ PRE-FILLED SALINE SYRINGE EXPERIENCED A BROKEN TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: BROKEN TUBE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE EXPERIENCED A BROKEN TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: BROKEN TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512364 BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON, S.A. 2152611

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown