BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1

    MDR report key: 12125790 · Received July 6, 2021

    Report

    Report Number
    3002682307-2021-00306
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 3, 2021
    Report Date
    August 23, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    K091377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 2012411, 2006428, 2006403 AND 2012414. 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. AS SAMPLES WERE UNAVAILABLE FOR RETURN, A THOROUGH ANALYSIS COULD NOT BE COMPLETED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1 HAD SCALE MARKING ISSUES ON 24 OCCASIONS AND AIR BUBBLES ON 6 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE HAVING MULTIPLES PROBLEMS WITH THE COMBINED NEEDLES & SYRINGES, I HAVE NOTIFIED THE MHRA AS HAVE MY COLLEAGUE. TONIGHT¿S INCIDENT REPORTS CONSIST OF THE FOLLOWING; LOT NO 2006 428 X 4 LEAKING AIR; LOT NO 2006 428 X 3/ SYRINGE MARKINGS NOT STRAIGHT ON SYRINGE; LOT NO 2006 403 X 1 LEAKING AIR; LOT NO 2012 414 X 1 BENT NEEDLE & MARKINGS NOT STRAIGHT ON SYRINGE; LOT NO 2012 414 X 18 MARKINGS NOT STRAIGHT ON SYRINGE; LOT NO 2012 411 X 1 AIR BUBBLES FROM BOTTOM OF SYRINGE; LOT NO 2012 411 X 2 MARKINGS NOT STRAIGHT ON SYRINGE.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2006428. MEDICAL DEVICE EXPIRATION DATE: 2025-05-31. DEVICE MANUFACTURE DATE: 2020-06-17. MEDICAL DEVICE LOT #: 2006403. MEDICAL DEVICE EXPIRATION DATE: 2025-05-31. DEVICE MANUFACTURE DATE: 2020-06-02. MEDICAL DEVICE LOT #: 2012414. MEDICAL DEVICE EXPIRATION DATE: 2025-11-30. DEVICE MANUFACTURE DATE: 2020-12-14. MEDICAL DEVICE LOT #: 2012411. MEDICAL DEVICE EXPIRATION DATE: 2025-11-30. DEVICE MANUFACTURE DATE: 2020-12-10. INITIAL REPORTER ADDRESS: (B)(6). INITIAL REPORTER ADDRESS: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1 HAD SCALE MARKING ISSUES ON 24 OCCASIONS AND AIR BUBBLES ON 6 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE HAVING MULTIPLES PROBLEMS WITH THE COMBINED NEEDLES & SYRINGES, I HAVE NOTIFIED THE MHRA AS HAVE MY COLLEAGUE. TONIGHT¿S INCIDENT REPORTS CONSIST OF THE FOLLOWING; LOT NO 2006 428 X 4 LEAKING AIR. LOT NO 2006 428 X 3/ SYRINGE MARKINGS NOT STRAIGHT ON SYRINGE. LOT NO 2006 403 X 1 LEAKING AIR. LOT NO 2012 414 X 1 BENT NEEDLE & MARKINGS NOT STRAIGHT ON SYRINGE. LOT NO 2012 414 X 18 MARKINGS NOT STRAIGHT ON SYRINGE. LOT NO 2012 411 X 1 AIR BUBBLES FROM BOTTOM OF SYRINGE. LOT NO 2012 411 X 2 MARKINGS NOT STRAIGHT ON SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021249 SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1 PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1