BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER-LOK SYRINGE

    MDR report key: 15518811 · Received September 30, 2022

    Report

    Report Number
    1911916-2022-00545
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    September 6, 2022
    Report Date
    October 26, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903010356
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THE SYRINGE MOLDING WAS DEFECTIVE CAUSING LEAKAGE. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS ARE MAGNIFIED TO SHOW A VISIBLE TIP FLASH. FROM THE PHOTOS, IT IS NOT POSSIBLE TO CONFIRM IF THE TIP FLASH IS OUT OF SPECIFICATION. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301035, LOT NUMBER 2040680. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AS WHAT IS SHOWN IN THE PHOTOS COULD BE AN IMPERFECTION. WITHOUT THE PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 02-NOV-2022. H6: INVESTIGATION SUMMARY: IT WAS REPORTED THE SYRINGE MOLDING WAS DEFECTIVE CAUSING LEAKAGE. TO AID IN THE INVESTIGATION, FIVE SAMPLES WITH NO PACKAGING BLISTER, AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND EACH SYRINGE HAS A TIP FLASH. EACH TIP FLASH WAS MEASURED AND ALL RESULTS WERE WITHIN SPECIFICATION. THE PHOTOS ARE MAGNIFIED TO SHOW A VISIBLE TIP FLASH. FROM THE PHOTOS, IT IS NOT POSSIBLE TO CONFIRM IF THE TIP FLASH IS OUT OF SPECIFICATION. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301035, LOT NUMBER 2040680. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED, AND A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE BD¿ LUER-LOK SYRINGE WAS DAMAGED AND CAUSED IT TO LEAK. THIS OCCURRED WITH 250 SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "CUSTOMER DESCRIBES THAT THERE IS A KIND OF WEB ON THE LUER-LOK CONNECTION, WHICH CAUSES IT TO LEAK".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE BD¿ LUER-LOK SYRINGE WAS DAMAGED AND CAUSED IT TO LEAK. THIS OCCURRED WITH 250 SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "CUSTOMER DESCRIBES THAT THERE IS A KIND OF WEB ON THE LUER-LOK CONNECTION, WHICH CAUSES IT TO LEAK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2479060 BD¿ LUER-LOK SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2040680 00382903010356

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown