BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 7735144 · Received July 31, 2018

    Report

    Report Number
    1213809-2018-00471
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    July 6, 2018
    Report Date
    August 27, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052722
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THE THREE USED SAMPLES THAT WERE RETURNED BY THE CUSTOMER FROM LOT 7235633 AND 8002923 SHOWED SIGNS THAT THE PLUNGER ROD COLLAPSED BEFORE THE END OF INJECTION; THE STOPPER WAS NOT BOTTOMED OUT, THE CUTTER WAS VISIBLE AND THE PLUNGER ROD WAS NOT FULLY DEPRESSED IN ALL OF THE RETURNED SAMPLES. A STYLET WAS RAN THROUGH EACH OF THE CANNULA AND THERE WERE NO INDICATIONS THAT THE CANNULA WAS CLOGGED. ADDITIONALLY, 600 PIECES FROM LOT 7235633 AND 8002923 SENT FROM DC CANADA WERE TESTED FOR PLUNGER ROD COLLAPSE AND STOPPER/HUB FORCE. ALL 600 SAMPLES WERE FOUND TO BE WITHIN THE SPECIFICATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. INVESTIGATION CONCLUSION: A LIST OF FINISHED GOOD LOTS WHICH WERE DISTRIBUTED IN CANADA WAS PROVIDED AND THE IN-PROCESS INSPECTIONS WERE PULLED FOR THIS CHARACTERISTIC (4,000 + SAMPLE). BETWEEN THE TWO LOTS WITH THE REPORTED ISSUE (7235633 AND 8002923), THEY SPANNED THE MAJORITY OF THE OBSERVED PROCESS VARIATION (BEFORE AND AFTER) THE REPORTED ISSUE. THERE IS NO INDICATION THAT THE SPECIFIC FORCES WOULD EXACERBATE THE CUSTOMER'S EXPERIENCE SINCE THEY HAD ISSUES WITH LOTS WITH BOTH "EASIER" AND "HARDER" TO COLLAPSE PLUNGER RODS. AT THIS POINT THERE IS NOTHING IN OUR INTERNAL DATA THAT WOULD INDICATED THAT THE TWO REPORTED LOTS ARE SUBSTANTIALLY DIFFERENT FROM ANY OTHER LOT CONSUMED IN TERMS OF PERFORMANCE. THE RECOMMENDATION FROM BD TO (B)(6) HOSPITAL ON (B)(6) 2018 WAS TO USE INTEGRA PRODUCTS WITH 21GA NEEDLE FOR A PERIOD OF TIME AND EVALUATE PRODUCT PERFORMANCE, THIS ACTION WAS RECOMMENDED BECAUSE WE BELIEVE THAT 21GA NEEDLES WILL PERFORM BETTER WITH THE HIGH VISCOSITY MEDICATIONS USED BY CUSTOMER. 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: B.2. EVENT ATTRIBUTED TO: OTHER. D.8. DEVICE SINGLE USE?: NO. H.3. DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USE OF THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE IT WOULD NOT RETRACT. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USE OF THE BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE IT WOULD NOT RETRACT. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577108 BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 7235633 30382903052722

    Patients

    Seq Age Sex Outcome Treatment
    1 Other