BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 ML BD LUER-LOK SYRINGE

    MDR report key: 11606002 · Received April 1, 2021

    Report

    Report Number
    1911916-2021-00275
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    March 4, 2021
    Report Date
    March 25, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    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

    INVESTIGATION SUMMARY: IT WAS REPORTED THE IMAGE OF THE SYRINGE ON THE LABEL DOES NOT MATCH THAT OF THE PRODUCT IN THE BOX. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS THE CASE LABEL WITH THE DRAWING OF A SLIP TIP SYRINGE; THE PRODUCT IS A LUER LOCK SYRINGE. THE LABEL SHOWS THE DRAWING WITHIN SPECIFICATION. THERE IS ONLY ONE DRAWING FOR ALL TYPE OF SYRINGE TIP BOXES. IT MAY BE THAT THE CUSTOMER IS NOT FAMILIAR WITH THE DRAWING SPECIFICATION FOR THESE PRODUCTS. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301031, LOT NUMBER 0031480. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. 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. INVESTIGATION CONCLUSION: WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THIS PRODUCT AND SYMPTOM. PROBABLE ROOT CAUSE. IT COULD BE POSSIBLE THAT THE CUSTOMER IS CONFUSED WITH OUR LABELING. OUR LABELS HAVE ONE DRAWING FOR ALL THE DIFFERENT TYPE OF SYRINGES. IT IS RECOMMENDED THAT HYPODERMIC MARKETING COMMUNICATES WITH THE CUSTOMER TELEFLEX TO EXPLAIN OUR LABELING SYSTEM AND BETTER UNDERSTAND THE CUSTOMER EXPECTATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(4) 20 ML BD LUER-LOK¿ SYRINGES EXPERIENCED INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301031, BATCH NO.: 0031480. WHILE PERFORMING THE INCOMING INSPECTION ON THIS BATCH, 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
    503692 20 ML BD LUER-LOK SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 0031480

    Patients

    Seq Age Sex Outcome Treatment
    1