BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE FLU PLUS 0.1-1ML VAR DOSE 23X1

    MDR report key: 11742504 · Received April 28, 2021

    Report

    Report Number
    3002682307-2021-00161
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 31, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 5/28/2021. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2102402. 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, BOTH PICTURE AND THREE PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH VISUAL EXAMINATION OF THE SAMPLES, NO LOOSE FOREIGN MATTER OR PARTICLES COULD BE OBSERVED. THE SAMPLES WERE SUBJECTED TO A COTTON SWAB TEST, WHICH CONSISTED OF RUBBING A COTTON STICK ALONG THE CANNULA SURFACE SEVERAL TIMES AND EXAMINING FOR SIGNS OF RESIDUE. THIS IS NOT AN ACCEPTABLE METHOD FOR CANNULA CLEANLINESS, BUT IS AN OBJECTIVE TEST TO OBTAIN A COMPARISON BETWEEN THE PROVIDED SAMPLES AND OTHER ¿REGULAR¿ SAMPLES. THE PROVIDED SAMPLES DISPLAYED A LACK OF RESIDUE AFTER THE COTTON SWAB TEST. IT IS POSSIBLE THAT THIS INCIDENT WAS RELATED TO SILICONE LUBRICANT OR SOME PARTICULATE MATTER FROM THE CANNULA MANUFACTURING PROCESS. IN PRIOR OCCASIONS, NO SIGNIFICANT AMOUNT OF RESIDUE WAS OBSERVED ON THE TESTED NEEDLES COMPARED TO OTHER BD LOT NUMBERS AND COMPETITOR SAMPLES. CLEANING AND TREATMENT PROCESSES ARE EMPLOYED TO MINIMIZE THE LEVEL OF RESIDUE PRESENT ON THE SURFACE OF THE CANNULA DURING THE NEEDLE FORMING PROCESS, BUT BASED ON CURRENT TECHNOLOGIES, ALL NEEDLES HAVE VARYING DEGREES OF LUBRICANT AND RESIDUAL MATTER ON THE CANNULA SURFACE WHICH SHOULD REPRESENT NEGLIGIBLE HEALTH RISK TO THE PATIENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE FLU PLUS 0.1-1ML VAR DOSE 23X1 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE LEAVES A DARK MARK ON THE SWAB AND SKIN OF THE VACCINATED PERSON. WE HAD ALREADY HAD PROBLEMS OF THIS TYPE WITH ANOTHER NEEDLE FROM ANOTHER COMPANY AND IN FACT WE HAD THEN VERIFIED, ALSO WITH THE UNIVERSITY OF TRENTO, THAT THE NEEDLE WAS NOT WELL SILICONED AND RELEASED STEEL PARTICLES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 0.1-1ML VAR DOSE 23X1 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE LEAVES A DARK MARK ON THE SWAB AND SKIN OF THE VACCINATED PERSON. WE HAD ALREADY HAD PROBLEMS OF THIS TYPE WITH ANOTHER NEEDLE FROM ANOTHER COMPANY AND IN FACT WE HAD THEN VERIFIED, ALSO WITH THE (B)(6), THAT THE NEEDLE WAS NOT WELL SILICONED AND RELEASED STEEL PARTICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632687 SYRINGE FLU PLUS 0.1-1ML VAR DOSE 23X1 SYRINGE FMF BECTON DICKINSON, S.A. 2102402

    Patients

    Seq Age Sex Outcome Treatment
    1