BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 60ML SYRINGE LUER-LOK TIP

    MDR report key: 11163454 · Received January 13, 2021

    Report

    Report Number
    1911916-2021-00018
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 15, 2020
    Report Date
    January 7, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653 AND LOT NUMBER 0140903. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, ONE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THE SAMPLE HAS LUER TIP DAMAGE. NO OTHER DEFECT OR IMPERFECTION WAS OBSERVED. ONE PHOTO WAS PROVIDED AND IT SHOWS THE SAMPLE RECEIVED. BASED ON THE INVESTIGATION WITH THE SAMPLE AND PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. IT COULD BE POSSIBLE FOR THIS DEFECT TO OCCUR DURING THE ASSEMBLY PROCESS. IT MAY HAVE BEEN THAT A JAM OCCURRED INDUCING THE LUER TIP DAMAGE. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. 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: BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. PROBABLE ROOT CAUSE. A JAM MAY HAVE OCCURRED IN THE SYRINGE ASSEMBLY PROCESS INDUCING THE LUER TIP DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD 60ML SYRINGE LUER-LOK" TIP EXPERIENCED A DAMAGED/CRACKED/DEFORMED TIP/LUER OF SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DAMAGED SYRINGE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58509 BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 0140903 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1