BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK TIP

    MDR report key: 8880908 · Received August 9, 2019

    Report

    Report Number
    1213809-2019-00816
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Date of Event
    July 15, 2019
    Report Date
    September 23, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THREE PHOTOS WERE RECEIVED AND EVALUATED. ONE PHOTO SHOWED 8 MARKED 10ML BARRELS WITH NO PLUNGER RODS. ONE PHOTO SHOWED A PART OF A SINGLE 10ML SYRINGE WITH A BROKEN THUMB REST ON ITS PLUNGER ROD. ONE PHOTO SHOWED A SINGLE 10ML SYRINGE WITH DAMAGE TO ITS BARREL OUTSIDE THE SCALE MARKINGS. IT WAS NOT POSSIBLE TO EVALUATE IT FURTHER DUE TO LOW PHOTO RESOLUTION. IT WAS NOT CLEAR WHICH BATCH THE SAMPLES IN PHOTOS BELONGED TO. PRODUCTION RECORDS INDICATE ASSEMBLY DIAL JAM OCCURRED DURING MANUFACTURE OF BATCH 9037845. ISSUES WITH BARREL JAM AND PLUNGER ROD DIAL DURING ASSEMBLY WERE RECORDED DURING MANUFACTURE OF BATCH 9081855. POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL, PLUNGER ROD, AND MISSING COMPONENT DEFECTS IS ASSOCIATED WITH THE ASSEMBLY PROCESS. BARRELS AND PLUNGER RODS MAY GET DAMAGED DURING A TEMPORARY JAM DURING ASSEMBLY. THE PRODUCT IS REJECTED, HOWEVER A LIMITED NUMBER MAY ESCAPE DETECTION. MISSING PLUNGER RODS CAN OCCUR IF PLUNGER RODS ARE ABSENT IN THE DIAL DURING ASSEMBLY WITH THE BARREL. SUCH AN INSTANCE IS POSSIBLE AFTER AN OCCURRENCE OF A PLUNGER ROD JAM. EMPTY BARRELS ARE DISCARDED, THOUGH IT IS POSSIBLE A LIMITED NUMBER COULD ESCAPE DETECTION. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCHES 9037845 AND 9081885 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE TWO PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PLUNGER ERROR OCCURRED WITH A BD 10ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "SYRINGES WITH MISSING PARTS, SYRINGES WITH DEFORMED SHAPE AND BROKEN SYRINGES".

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9037845, MEDICAL DEVICE EXPIRATION DATE: 2024-01-31, DEVICE MANUFACTURE DATE: 2019-02-06. MEDICAL DEVICE LOT #: 9081855, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-03-22. DEVICE EVALUATED BY MFR: 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 PLUNGER ERROR OCCURRED WITH A BD 10ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "SYRINGES WITH MISSING PARTS; SYRINGES WITH DEFORMED SHAPE; BROKEN SYRINGES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674642 BD 10ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other