BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 5ML

    MDR report key: 10210449 · Received June 30, 2020

    Report

    Report Number
    3002682307-2020-00203
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    June 3, 2020
    Report Date
    July 27, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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: 2020-06-25. H.6. INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 2002128 AND 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, BOTH PICTURE AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, ONE EMERALD 5ML SYRINGE WAS OBSERVED PACKAGED WITHIN A LOT OF DISCARDIT 5ML SYRINGES. IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED FROM AN ERROR IN THE PRIMARY PACKAGING PROCESS. THE PRODUCTION LINE WAS NOT PROPERLY CLEARED OF ALL PREVIOUS PRODUCT PRIOR TO THE PRODUCTION OF THE NEW PRODUCT. THERE ARE SEVERAL PREVENTIVE MEASURES IN PLACE TO TO INHIBIT THIS TYPE OF INCIDENT FROM OCCURRING AND WE ARE CONFIDENT THAT THIS WAS AN ISOLATED INCIDENT. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE S2 5ML EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUG AND PISTON ROD WRONG: WE ARE CONTACTING YOU TO NOTIFY A DETECTED DEVIATION FROM A DELIVERY MADE FROM THE BELOW BD PRODUCT: MATERIAL: 5 ML CONE LUER SYRINGE BATCH: 2002128 20,000 UNITS OF THE ABOVE MATERIAL WERE RECEIVED ON (B)(6) 2020. AFTER SAMPLING, IT WAS DETECTED THAT ONE OF THE SYRINGES HAS TWO COMPONENTS OUT OF SPECIFICATION, SPECIFICALLY, A GREEN STOPPER (THERE SHOULD BE NO STOPPER); PLUNGER ROD & THUMB PRESS ARE TRANSLUCENT (INSTEAD OF WHITE).

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE S2 5ML EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUG AND PISTON ROD WRONG: WE ARE CONTACTING YOU TO NOTIFY A DETECTED DEVIATION FROM A DELIVERY MADE FROM THE BELOW BD PRODUCT: MATERIAL: 5 ML CONE LUER SYRINGE BATCH: 2002128. 20,000 UNITS OF THE ABOVE MATERIAL WERE RECEIVED ON (B)(6) 2020. AFTER SAMPLING, IT WAS DETECTED THAT ONE OF THE SYRINGES HAS TWO COMPONENTS OUT OF SPECIFICATION, SPECIFICALLY, A GREEN STOPPER (THERE SHOULD BE NO STOPPER); PLUNGER ROD & THUMB PRESS ARE TRANSLUCENT (INSTEAD OF WHITE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679653 SYRINGE S2 5ML SYRINGE FMF BECTON DICKINSON, S.A. 2002128

    Patients

    Seq Age Sex Outcome Treatment
    1 Other