BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 11529711 · Received March 19, 2021

    Report

    Report Number
    1213809-2021-00150
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 11, 2021
    Report Date
    March 15, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 #: 0031484 MEDICAL DEVICE EXPIRATION DATE: 2025-01-31 DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0031483 MEDICAL DEVICE EXPIRATION DATE: 2025-01-31 DEVICE MANUFACTURE DATE: (B)(6) 2020. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 301031 AND LOT NUMBERS 0031483 AND 0031484. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. THESE PRODUCTS ARE LABELED ACCORDING TO THE SPECIFICATIONS. THE LABELS ONLY HAVE ONE DRAWING REGARDLESS OF THE LUER TYPE. BASED ON THE INVESTIGATION RESULTS, WITH NO SAMPLE RETURNED, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 325 BOXES OF BD LUER-LOK¿ SYRINGES FROM LOT 0031484, AND 35425 BOXES FROM LOT 0031483 HAD INCORRECT LABEL INFORMATION ON THEM, SHOWING AN IMAGE OF A LUER SLIP TIP SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE PERFORMING THE INCOMING INSPECTION ON THIS BATCH, THE INSPECTOR FOUND THAT THE DIAGRAM OF THE SYRINGE TIP IS INCORRECT ON THE OUTSIDE OF THE BOX. THE OUTSIDE LABEL ON THE BOXES HAD AN IMAGE OF A LUER SLIP TIP SYRINGE BUT THIS PRODUCT IS A LUER LOCK TIP SYRINGE. THE VENDOR PART NUMBER AND THE SYRINGE (20ML LUER LOCK) INSIDE ARE BOTH CORRECT FOR THIS PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427086 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1