BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 50ML LL

    MDR report key: 10247923 · Received July 8, 2020

    Report

    Report Number
    3003152976-2020-00293
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 16, 2020
    Report Date
    July 17, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: 6/25/2020. H.6. INVESTIGATION: SIX SYRINGES FROM CLAIMED LOT REPORTED 2001270 HAVE BEEN RECEIVED IN THEIR UNOPENED UNITARY PACKAGE. AFTER THE INSPECTION OF THE CLAIMED SAMPLES RECEIVED IT CAN BE OBSERVED THE PAPER FROM THE UNITARY PACKAGING CRUMPLED AND WITH BROWN STAINS ON IT IS SURFACE FOR ALL SAMPLES RECEIVED. MOREOVER, ONE PICTURE SHOWING THE SHIPPING BOX WAS ALSO RECEIVED BY THE CUSTOMER. BASED ON THE PICTURE RECEIVED, HUMIDITY ON THE TOP OF THE SHIPPING BOX AND DAMAGES ARE NOTICED. IT SEEMS THAT THE OUTER CARTON IS DAMAGED, CRUMPLED AND WET. CUB PACK WAS BROKEN. BASED ON SAMPLE INSPECTION AND PICTURE RECEIVED IT MAY BE STATED THAT HUMIDITY ENTERED INSIDE THE SHIPPING BOX LEADING TO DAMP CARTONS AND BROWN STAINS ON THE PAPER FROM THE UNIT PACKAGES COMING FROM WET CARTON MATERIAL. ALTHOUGH THE OUTER CARTON AND THE UNIT PACKAGE PAPER WERE AFFECTED BY THE ISSUE REPORTED, AFTER OPENING ALL THE PACKAGES AND AN INSPECTION OF ALL SYRINGES RECEIVED NO DAMAGES OR HUMIDITY COULD BE DETECTED ON ALL SAMPLES RECEIVED. DHR OF LOT 2001270 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. THE FAILURE MODES AND EFFECTS ANALYSIS FOR PROCESSES P-EURA RM852 PLASTIPAK SYRINGES PACKAGING WAS REVIEWED AND FAILURE ADEQUATELY ASSESSED. AFTER BEING STERILIZED THE PRODUCT IS SENT TO BD TEMSE DISTRIBUTION CENTER. AFTER AN INVESTIGATION THE DC CAN CONFIRMED THAT NO WET OR DAMAGED PACKAGES OR SHIPPING BOXES WERE RECEIVED IN THEIR SITE, RULING THE POSSIBILITY OF ANY INCIDENCE IN BD SAN AGUSTIN MANUFACTURING SITE NOT BD FRAGA STERILIZATION SITE. THEREFORE: IT SEEMS THAT PROBABLY THE ROOT CAUSE OF THE EVENT REPORTED MAY BE LOCATED DURING THE TRANSPORT/DISTRIBUTION OF THE PRODUCT TO THE CUSTOMER. NEVERTHELESS, AS THE ROOT CAUSE IS OUT OF THE SCOPE OF BD MANUFACTURING SITE, THIS HYPHOTESIS CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE THE SHIPPING BOX WAS WET AND THE PRIMARY PACKAGING HAD "RUST" STAINS WITH 360 BD SYRINGE 50ML LL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON UNPACKAGING IT WAS NOTED THAT OUTER BOXES WERE WET AND THERE WAS CHECKER PLATE RUST STAINS ON THE PLASTIC PACKAGING. 6 BOXES HAD TO BE DISCARDED AS COULD NOT BE USED.

    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 PRIOR TO USE THE SHIPPING BOX WAS WET AND THE PRIMARY PACKAGING HAD "RUST" STAINS WITH 360 BD SYRINGE 50ML LL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON UNPACKAGING IT WAS NOTED THAT OUTER BOXES WERE WET AND THERE WAS CHECKER PLATE RUST STAINS ON THE PLASTIC PACKAGING. 6 BOXES HAD TO BE DISCARDED AS COULD NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712733 BD SYRINGE 50ML LL PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2001270

    Patients

    Seq Age Sex Outcome Treatment
    1 Other