BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH SF SALINE SYRINGE

    MDR report key: 10519165 · Received September 10, 2020

    Report

    Report Number
    9616657-2020-00141
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Date of Event
    August 21, 2020
    Report Date
    November 20, 2020
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065531
    PMA / PMN Number
    K153481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 0090278 AND 0062230. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, SEVENTEEN PHYSICAL SAMPLES BELONGING TO LOT NUMBER 0090278 AND TWENTY-NINE PHYSICAL SAMPLES BELONGING TO LOT NUMBER 0062230 WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, THE PRODUCT PACKAGES WERE OBSERVED DAMAGED. AT THIS TIME, A SINGLE CAUSE HAS NOT BEEN ASSIGNED FOR THIS DEFECT. THIS ISSUE HAS BEEN ESCALATED AND IS BEING INVESTIGATED WITH PLANT ENGINEERING LEADERSHIP. A CORRECTIVE AND PREVENTIVE ACTION PLAN HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE AND PREVENT IT'S RECURRENCE. THE INVESTIGATION HAS A SPECIFIC FOCUS ON THE HANDLING AND PACKAGING OF THE BLISTER PACKAGES. THIS ONGOING INVESTIGATION WILL BE TRACKED AND TRENDED AND COMMUNICATED ACCORDINGLY. CAPA 1833142 HAS BEEN RAISED TO TRACK THE CORRECTIVE ACTIONS FOR THIS PACKAGING ISSUE. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 28 BD POSIFLUSH¿ SF SALINE SYRINGE PACKAGING UNITS FROM LOT 0062230, AND AN UNSPECIFIED NUMBER OF UNITS FROM LOT 0090278, WERE FOUND WITH TEARS IN THEM BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OPERATORS FOUND THE STERILE SALINE SYRINGES TO HAVE A TEAR IN THE POUCH" "BD LOT 0062230 ALSO HAS BEEN FOUND TO HAVE PIECES WITH TEARS IN THE TYVEK SIDE OF THE POUCH."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0062230, MEDICAL DEVICE EXPIRATION DATE: 2023-02-28, DEVICE MANUFACTURE DATE: 2020-03-02. MEDICAL DEVICE LOT #: 0090278, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2020-03-30. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 28 BD POSIFLUSH" SF SALINE SYRINGE PACKAGING UNITS FROM LOT 0062230, AND AN UNSPECIFIED NUMBER OF UNITS FROM LOT 0090278, WERE FOUND WITH TEARS IN THEM BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OPERATORS FOUND THE STERILE SALINE SYRINGES TO HAVE A TEAR IN THE POUCH" "BD LOT 0062230 ALSO HAS BEEN FOUND TO HAVE PIECES WITH TEARS IN THE TYVEK SIDE OF THE POUCH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983737 BD POSIFLUSH SF SALINE SYRINGE INTRAVASCULAR CATHETER NGT BECTON, DICKINSON AND CO. 306553 SEE SECTION H.10. 30382903065531

    Patients

    Seq Age Sex Outcome Treatment
    1 Other