BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1

    MDR report key: 12132560 · Received July 7, 2021

    Report

    Report Number
    3002682307-2021-00308
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 7, 2021
    Report Date
    August 24, 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 SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, A PICTURE SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, THE NEEDLE WAS OBSERVED BENT. IT HAS BEEN DETERMINED THAT THE BENT NEEDLE COULD HAVE BEEN PRODUCED DURING THE LAST STEP OF THE CANNULATING MACHINE, WHEN THE NEEDLE SHIELD IS INTRODUCED TO THE PRODUCT. DUE TO SOME INEFFICIENT ADJUSTMENT, THE SHIELD WAS INCORRECTLY POSITIONED ONTO THE PRODUCT AND BENT THE CANNULA. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST 5 SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1 EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE¿VE HAD 5 REPORTS TODAY OF THE NEEDLES/SYRINGES LEAKING TOO. WE NOW HAVE 5 BOXES IN QUARANTINE IN PHARMACY AND THERE ARE 14 BOXES WITH THE SAME BATCH NUMBER ON THE SHOP FLOOR. ARE YOU SAYING THAT STAFF HAVE FOUND 5-10 BENT NEEDLES PER ROUGHLY HALF A BOX? OR IS IT 5-10 ISSUES (BOTH BENT NEEDLES AND LEAKING): THE FORMER, EITHER BENT OR LEAKING ¿ AS FAR AS I¿M AWARE NOT THE TWO TOGETHER.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT AT LEAST 5 SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1 EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE¿VE HAD 5 REPORTS TODAY OF THE NEEDLES/SYRINGES LEAKING TOO. WE NOW HAVE 5 BOXES IN QUARANTINE IN PHARMACY AND THERE ARE 14 BOXES WITH THE SAME BATCH NUMBER ON THE SHOP FLOOR. ARE YOU SAYING THAT STAFF HAVE FOUND 5-10 BENT NEEDLES PER ROUGHLY HALF A BOX? OR IS IT 5-10 ISSUES (BOTH BENT NEEDLES AND LEAKING): THE FORMER, EITHER BENT OR LEAKING ¿ AS FAR AS I¿M AWARE NOT THE TWO TOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022917 SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1 SYRINGE FMF BECTON DICKINSON, S.A. 2012414

    Patients

    Seq Age Sex Outcome Treatment
    1