BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER-LOK SYRINGE

    MDR report key: 7718233 · Received July 25, 2018

    Report

    Report Number
    1911916-2018-00392
    Event Type
    Malfunction
    Date Received
    July 25, 2018
    Date of Event
    July 2, 2018
    Report Date
    August 28, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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: YES. INVESTIGATION SUMMARY: 30 SAMPLES WERE RETURNED FOR EVALUATION AND REPORTED TO BE FROM LOTS 7227660, 7227702, 7170626, 7170622, 7170606, 7227658, 7170608 AND 7170624. THE SAMPLES WERE VISUALLY EVALUATED WITH THE FOLLOWING RESULTS: 7227660 - "PRINT ISSUES" - ONE SYRINGE HAD INK DOTS. TWO SYRINGES HAD MINOR MISSING PRINT. 7227702 - "PRINT ISSUES" - THREE SYRINGES HAD RUBMARKS. 7170626 - "PRINT ISSUES" - ONE SYRINGE HAD MINOR MISSING PRINT. 7170622 - "PRINT ISSUES" - TWO SYRINGES HAD INK RINGS 7170606 - "PRINT ISSUES" - TWO SYRINGES HAD RUBMARKS 7227658 - "PRINT ISSUES" - ONE SYRINGE HAD INK DOTS. ONE SYRINGE HAD MISSING MINOR PRINT. ONE SYRINGE HAD RUBMARKS. 7227660 - "BUBBLES" - TWO SYRINGES HAD BUBBLES 7227702 - "FM" - THREE SYRINGES HAD EMBEDDED FOREIGN MATTER 7170626 - "FM" - ONE SYRINGE HAD EMBEDDED FOREIGN MATTER 7227658 - "FM" - TWO SYRINGES HAD EMBEDDED FOREIGN MATTER 7170622 - "DAMAGE" - ONE SYRINGE HAD BARREL DAMAGE. ONE SYRINGE HAD PLUNGER ROD DAMAGE. 7227658 -"DAMAGE" - TWO SYRINGES HAD PLUNGER ROD DAMAGE. 7170608 -"DAMAGE" - TWO SYRINGES HAD PLUNGER ROD DAMAGE. 7170624-"DAMAGE" - ONE SYRINGE HAD PLUNGER ROD DAMAGE. 7170624 - ONE SYRINGE HAD SHORT SHOD RODS. PROBABLE ROOT CAUSES: BUBBLES: VENTS ON MOLD PARTIALLY PLUGGED WITH PLASTIC GAS DISCHARGE PREVENTING/OBSTRUCTING PRIMARY VENT DISCHARGE OR MOLD MELT DISK PROBES PARTIALLY OBSTRUCTED WHICH CREATES A JETTING EFFECT IN THE PLASTIC FLOW. IN TURN, THIS CREATES HEAD AND UNEVEN FLOW THROUGH THE GATES AND CAUSES BUBBLES. INK DOTS: INK DOTS CAN OCCUR AFTER THE GRADUATION SCALE PRINTING PROCESS. DURING TRANSPORT BETWEEN THE PRINTING, ASSEMBLY, AND PACKAGING PROCESSES, SYRINGES CAN MAKE CONTACT WITH EACH OTHER. IT IS POSSIBLE THAT DURING CONTACT, INK FROM THE GRADUATION SCALE CAN TRANSFER BETWEEN SYRINGES CAUSING DOTS OF INK. RUBMARKS, MINOR MISSING PRINT (CAUSED BY RUBMARKS): MISSING PRINT IS CONSIDERED ACCEPTABLE IF UNDER 50% OF ANY GIVEN ITEM (NUMBER, LETTER, OR GRADUATION LINE) IS MISSING AND STILL LEGIBLE. A RUBMARK IS LIKELY CAUSED BY A BARREL OR PLUNGER ROD GETTING CAUGHT IN THE MACHINERY AND MAKING CONTACT WITH SYRINGES AS THEY ARE BEING PROCESSED. EMBEDDED FM: EMBEDDED FM CAN OCCUR AT THE STARTUP OF AN INJECTION MOLD/PRESS OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. DEGRADED RESIN INHERENTLY BUILDS UP IN THE BARREL AND HOT-RUNNER SYSTEM OF THE MOLD AND PRESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. BARREL DAMAGE: THE BARREL DAMAGE ON THE SAMPLE APPEARED TO HAVE BEEN CAUSED BY A MISFEED OF THE BARREL INTO THE TRANSTECH BARREL PRINTER. THIS MISFEED COULD HAVE BEEN CAUSED BY BARRELS NOT FEEDING QUICKLY ENOUGH INTO THE PRINTER AND CAUSING A PART TO GET STUCK WHEN THE STARWHEEL TOOK THE BARREL FROM THE INFEED RAIL. BROKEN / CRACKED PLUNGER RODS: THE CRACKED AND BROKEN PLUNGER RODS ARE LIKELY CAUSED BY SOME MINOR MISALIGNMENT WHEN THE PLUNGER ROD IS ASSEMBLED TO THE BARREL. IF PARTS FEED TOO SLOWLY INTO THE ASSEMBLY MACHINE, IT CAN CAUSE THIS MISALIGNMENT. IF THE PLUNGER ROD IS NOT EVENLY PUSHED INTO THE BARREL, IT CAN PUT STRESS ON THE PLUNGER ROD AND DAMAGE THE PART. SHORT SHOT: THIS OCCURS DURING THE MOLDING PROCESS IF THE PART IS NOT COMPLETELY PACKING OUT DUE TO LOW PACK PRESSURE AND PACK TIME. THIS CAN CAUSE THE PART TO NOT BE FULLY FORMED. INK RINGS: INK RINGS ARE GENERATED DURING THE GRADUATION SCALE PRINTING PROCESS. INK RINGS ARE CAUSED BY A DAMAGED DOCTOR BLADE. THE DOCTOR BLADE WIPES EXCESS INK OFF THE PRINT ETCHING WHICH TRANSFERS THE GRADUATION SCALE PATTERN ONTO THE PRINTING PAD. WHEN THE BLADE IS DAMAGED, IT WILL NOT WIPE THE EXCESS INK OFF OF THE ETCHING CAUSING A BLACK LINE TO BE PRINTED ON THE BARREL. NO CORRECTIVE ACTIONS REQUIRED. AS SHOWN IN ATTACHMENT, DEFECT RATES ARE ALL WITHIN ALLOWED LIMIT¿S PER BD¿S SPECIFICATIONS. HOWEVER, FOR INK DOTS A CAPA HAS BEEN OPENED TO IMPROVE THE INK CURING PROCESS AND REDUCE CONTACT BETWEEN SYRINGES TO MITIGATE INK DOT ISSUES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ LUER-LOK SYRINGE HAD "PARTICULATE CONTAMINATION, DAMAGE, INCLUSIONS, PRINT ISSUE, AND MISALIGNED GASKET". NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7170606, MEDICAL DEVICE EXPIRATION DATE: 06/30/2022, DEVICE MANUFACTURE DATE: 06/19/2017. MEDICAL DEVICE LOT #: 7170622, MEDICAL DEVICE EXPIRATION DATE: 06/30/2022 , DEVICE MANUFACTURE DATE: 06/19/2017. MEDICAL DEVICE LOT #: 7170624, MEDICAL DEVICE EXPIRATION DATE: 06/30/2022, DEVICE MANUFACTURE DATE: 06/19/2017. MEDICAL DEVICE LOT #: 7170625, MEDICAL DEVICE EXPIRATION DATE: 06/30/2022, DEVICE MANUFACTURE DATE: 06/19/2017. MEDICAL DEVICE LOT #: 7170626, MEDICAL DEVICE EXPIRATION DATE: 06/30/2022, DEVICE MANUFACTURE DATE: 06/19/2017. MEDICAL DEVICE LOT #: 7227658, MEDICAL DEVICE EXPIRATION DATE: 08/31/2022, DEVICE MANUFACTURE DATE: 08/15/2017. MEDICAL DEVICE LOT #: 7227660, MEDICAL DEVICE EXPIRATION DATE: 08/31/2022, DEVICE MANUFACTURE DATE: 08/15/2017. MEDICAL DEVICE LOT #: 7227702, MEDICAL DEVICE EXPIRATION DATE: 08/31/2022, DEVICE MANUFACTURE DATE: 08/15/2017. 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¿ LUER-LOK SYRINGE HAD "PARTICULATE CONTAMINATION, DAMAGE, INCLUSIONS, PRINT ISSUE, AND MISALIGNED GASKET". NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560418 BD¿ LUER-LOK SYRINGE SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other