BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 7781208 · Received August 14, 2018

    Report

    Report Number
    1213809-2018-00521
    Event Type
    Malfunction
    Date Received
    August 14, 2018
    Date of Event
    July 23, 2018
    Report Date
    August 27, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: NO. NVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. DHR REVIEW SHOWED RELEASE DATE: 02/12/2018. RELEASED QUANTITY WAS (B)(4). STOPPER ANGULARITY DEFECTS WERE FOUND DURING THE MANUFACTURE OF THIS BATCH. ADJUSTMENTS WERE MADE AND PRODUCT WAS REQUALIFIED PER APPLICABLE AQL BEFORE PRODUCTION RESUMED. BATCH 8002915 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLES HAD STOPPER ANGULARITY OR IRREGULAR PLUNGER SIZE. THIS CONDITION RESULTED IN VOLUMETRIC INACCURACY. IT WAS ALSO REPORTED THAT ON ONE SYRINGE THE RUBBER STOPPER END HAD SEPARATED FROM THE PLUNGER ROD. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    FDA NOTIFIED: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 07/09/2018 MEDWATCH # MW5078343. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLES HAD STOPPER ANGULARITY OR IRREGULAR PLUNGER SIZE. THIS CONDITION RESULTED IN VOLUMETRIC INACCURACY. IT WAS ALSO REPORTED THAT ON ONE SYRINGE THE RUBBER STOPPER END HAD SEPARATED FROM THE PLUNGER ROD. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624686 BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 8002915 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 Other