BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 10318031 · Received July 23, 2020

    Report

    Report Number
    1213809-2020-00486
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    July 9, 2020
    Report Date
    July 13, 2020
    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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0003673. MEDICAL DEVICE EXPIRATION DATE: 2024-12-31. DEVICE MANUFACTURE DATE: 2020-01-03. MEDICAL DEVICE LOT #: 9336260. MEDICAL DEVICE EXPIRATION DATE: 2024-11-30. DEVICE MANUFACTURE DATE: 2019-12-02. MEDICAL DEVICE LOT #: 0003666. MEDICAL DEVICE EXPIRATION DATE: 2024-12-31. DEVICE MANUFACTURE DATE: 2020-01-03. (B)(4). INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED AND EVALUATED. IT SHOWS A LABEL WITH THE DRAWING OF LUER SLIP INSTEAD OF LUER LOK. THE PRODUCT LABELING IS ACCORDING TO OUR CURRENT LABELING SPECIFICATION. WE HAVE ONE DRAWING TYPE THAT GOES TO ALL LABELS REGARDLESS OF THE PRODUCT TYPE. THE POTENTIAL ROOT CAUSE FOR MIXED PRODUCT/LOTS IS ASSOCIATED WITH ONE DRAWING FOR ALL PRODUCT TYPES IS IN OUR LABELING DRAWING SPECIFICATIONS. BASED ON THE INVESTIGATION AND WITH THE PHOTO PROVIDED THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. A PROJECT IS TO BE OPENED TO REQUEST A DRAWING FOR EACH SYRINGE TYPE. THIS IS THE 1ST COMPLAINT FOR LOT #S 0003673, 9336260 & 0003666 FOR THIS TYPE OF DEFECT OR SYMPTOM. 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. 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. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT #S 0003673, 9336260 & 0003666 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: THE POTENTIAL ROOT CAUSE FOR MIXED PRODUCT/LOTS IS ASSOCIATED WITH ONE DRAWING FOR ALL PRODUCT TYPES IS IN OUR LABELING DRAWING SPECIFICATIONS. RATIONALE: BASED ON THE INVESTIGATION AND WITH THE PHOTO PROVIDED THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. A PROJECT IS TO BE OPENED TO REQUEST A DRAWING FOR EACH SYRINGE TYPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMAGE/DIAGRAM OF THE BD LUER-LOK¿ SYRINGE TIP ON THE OUTER BOX LABEL WAS INCORRECT, AS IT HAD AN IMAGE OF A LUER SLIP TIP RATHER THAN A LUER LOCK TIP. THIS WAS NOTICED PRIOR TO USE, WITH 650 SYRINGES IN LOT 0003673, 8775 SYRINGES IN LOT 9336260, AND 650 SYRINGES IN LOT 0003666. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE INSPECTOR FOUND THAT THE IMAGE/ DIAGRAM OF THE SYRINGE TIP IS INCORRECT ON THE OUTSIDE LABEL ON THE BOX. THE OUTSIDE LABEL ON THE BOXES HAS 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 CORRECT FOR THIS PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782270 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other