BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 ML BD¿ SYRINGE WITH LUER-LOK¿ TIP

    MDR report key: 7720357 · Received July 25, 2018

    Report

    Report Number
    1911916-2018-00391
    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

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 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. FOUR SAMPLES WERE RETURNED FROM BATCH 7227696. TWO SYRINGES HAD INK DOTS ON THEM. ONE SYRINGE HAD A DAMAGED PLUNGER ROD. ONE SYRINGE DID NOT HAVE ANY DEFECTS. SIX SAMPLES WERE RETURNED FROM BATCH 7170591. TWO SYRINGES HAD DAMAGED PLUNGER RODS. TWO SYRINGES HAD AN INK SMEAR ON THEM. TWO SYRINGES HAD INK DOTS ON THEM. 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. THE PLUNGER ROD DAMAGE LIKELY OCCURRED DURING A JAM IN THE ASSEMBLY MACHINE. IF A PLUNGER ROD MISS FEEDS INTO THE ASSEMBLY MACHINE, IT CAN CAUSE JAMS OR BREAK THE BARRELS AND PLUNGER RODS. SMEARED PRINT CAN OCCUR WHEN THE PRINTING PAD IS WORN DOWN, THE PRESSURE FROM THE PAD TO THE BARREL IS LOW, OR WHEN THE OUTFEED PRINTER CHAIN IS OUT OF TIME BECAUSE OF A JAM IN THE PRINTER. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. DEFECT RATES ARE WITHIN ALLOWED QUALITY LIMITS PER BD¿S SPECIFICATIONS. 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. 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 THE 30 ML BD SYRINGE WITH LUER-LOK TIP HAD MULTIPLE ISSUES NOTICED BEFORE USE SUCH AS PARTICULATE CONTAMINATION, DAMAGE, AND INCLUSIONS. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7170591; MEDICAL DEVICE EXPIRATION DATE: 06/30/2022; DEVICE MANUFACTURE DATE: 06/19/2017; MEDICAL DEVICE LOT #: 7227696; 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 THE 30 ML BD¿ SYRINGE WITH LUER-LOK¿ TIP HAD MULTIPLE ISSUES NOTICED BEFORE USE SUCH AS PARTICULATE CONTAMINATION, DAMAGE, AND INCLUSIONS. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559846 30 ML BD¿ SYRINGE WITH LUER-LOK¿ TIP SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other