BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 11108355 · Received January 4, 2021

    Report

    Report Number
    1911916-2020-01164
    Event Type
    Malfunction
    Date Received
    January 4, 2021
    Date of Event
    December 7, 2020
    Report Date
    January 8, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 170298. 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 INCIDENT, ONE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. IT CAME IN AN OPENED PACKAGING BLISTER AND A VISUAL INSPECTION WAS PERFORMED. THE SYRINGE BARREL HAS EMBEDDED DEGRADED RESIN. THE CAUSE FOR THIS DEFECT COULD HAVE RESULTED DURING THE SYRINGE MOLDING PROCESS, WHERE THE EMBEDDED RESIN BUILDS UP IN THE HOT RUNNER SYSTEM AND CAN BECOME LOOSE, BREAK OFF AND BECOME MOLDED INTO THE COMPONENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL TIP 1ML HAD FOREIGN MATTER IN THE BARREL OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309653, BATCH NO.: 0170298. IT WAS REPORTED THAT A BROWN STAIN OR FOREIGN OBJECT WAS FOUND ON AND IN THE BARREL OF THE SYRINGE. PER COMPLAINT FORM: A STAFF MEMBER OPENED THE PACKAGING OF A 50ML SYRINGE TO PREPARE FOR MIXING UP A MEDICATION. UPON OPENING THE PACKAGING IT WAS NOTED THAT THERE IS A BROWN STAIN ON AND IN THE BARREL OF THE SYRINGE. THE STAINING WAS NOT NOTICED UNTIL AFTER THE PACKAGING WAS OPENED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50ML LL TIP 1ML HAD FOREIGN MATTER IN THE BARREL OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309653 BATCH NO.: 0170298. IT WAS REPORTED THAT A BROWN STAIN OR FOREIGN OBJECT WAS FOUND ON AND IN THE BARREL OF THE SYRINGE. PER COMPLAINT FORM: A STAFF MEMBER OPENED THE PACKAGING OF A 50ML SYRINGE TO PREPARE FOR MIXING UP A MEDICATION. UPON OPENING THE PACKAGING IT WAS NOTED THAT THERE IS A BROWN STAIN ON AND IN THE BARREL OF THE SYRINGE. THE STAINING WAS NOT NOTICED UNTIL AFTER THE PACKAGING WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11268 SYRINGE 50ML LL TIP 1ML PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 0170298 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1