BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 7544993 · Received May 25, 2018

    Report

    Report Number
    1213809-2018-00310
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Date of Event
    May 7, 2018
    Report Date
    June 14, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052708
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: A SINGLE LOOSE 3ML INTEGRA SYRINGE REPORTED TO BE FROM BATCH # 7030994 (P/N 305270) AND A 150MG MEDICINE VIAL LABELED MEDROXYPROGESTERONE IN A ZIPLOC BAG WERE RECEIVED. THE SAMPLE WAS VISUALLY EVALUATED. WHITE MEDICINE RESIDUE WAS OBSERVED THROUGHOUT THE INSIDE OF THE BAG, THE SYRINGE FLUID PATH, THE FLANGE, PLUNGER ROD AND THE BARREL OUTSIDE THE FLUID PATH. THE NEEDLE RETRACTION MECHANISM WAS ACTIVATED, HOWEVER THE STOPPER WAS FOUND TO NOT BE BOTTOMED OUT (ABOVE THE ZERO LINE) WITH THE PLUNGER THUMBREST WAS SLIGHTLY ABOVE THE BARREL SHROUD. THIS POTENTIALLY INDICATES PREMATURE ACTIVATION. NO OTHER TESTING WAS PERFORMED DUE TO THE PRODUCT HAVING BEEN CONTAMINATED AND NEEDLE ACTIVATED AT WHICH POINT THE STOPPER HAD BEEN PUNCTURED AND ITS FUNCTION COULD NOT BE TESTED. THE MEDICINE RESIDUE OBSERVED WAS MOSTLY DRY SOLIDS, INDICATING IT WAS LIKELY A DENSE SUBSTANCE, INCREASING DIFFICULTY IN THE USE OF THE PRODUCT AND INCREASING THE LIKELIHOOD OF PREMATURE NEEDLE RETRACTION. NO OTHER DEFECT WAS OBSERVED IN THE SYRINGE AND BASED ON THE EVIDENCE PROVIDED DEFECT REPORTED BY THE END USER COULD NOT CONFIRMED TO BE A MANUFACTURING DEFECT. DHR REVIEW FOR BATCH 7030994 (P/N 305270): MANUFACTURING DATES: 02/24/2017 TO 02/26/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7030994 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. INVESTIGATION CONCLUSION: NO OTHER DEFECT WAS OBSERVED IN THE SYRINGE AND BASED ON THE EVIDENCE PROVIDED DEFECT REPORTED BY THE END USER COULD NOT CONFIRMED TO BE A MANUFACTURING DEFECT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER ROD OF A BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE, WAS DIFFICULT TO MOVE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389095 BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE SAFETY SYRINGE WITH NEEDLE MEG BECTON DICKINSON MEDICAL SYSTEMS 7030994 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 Other