BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 17716765 · Received September 9, 2023

    Report

    Report Number
    1911916-2023-00648
    Event Type
    Malfunction
    Date Received
    September 9, 2023
    Date of Event
    August 24, 2023
    Report Date
    September 22, 2023
    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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 2023-09-19. H.6. INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS ORANGE RESIDUE ON FOUR SYRINGES. TO AID IN THE INVESTIGATION, FOUR SAMPLES IN SEALED PACKAGING BLISTERS AND ONE PHOTO WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE PACKAGING BLISTER TOP WEBS HAVE RESIDUES OF ORANGE INK. THE PHOTO PROVIDED SHOWS THE SAMPLES RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THE PRINTER WAS NOT PROPERLY PURGED LEAVING RESIDES OF ORANGE INK. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 3110741. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLES WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. 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. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ORANGE RESIDUE WAS FOUND ON THE PACKAGES AND IN THE BOX OF BD LUER-LOK¿ TIP SYRINGES WHILE UNPACKING THE BOX. THIS WAS FOUND WITH 4 SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DETAIL: ORANGE RESIDUE ON 4 SYRINGES THAT WERE AT THE BOTTOM OF THE BOX. FOUND AS THE BOX WAS BEING UNPACKED TO TAKE TO UNIT. NO PREVIOUS EXPOSURE OUTSIDE THE BOX. BOX IS UNDAMAGED. UNKNOWN ORIGIN OF RESIDUE. NUMBER OF OCCURRENCES: 4.0... RESPONSE RECEIVED ON 01-SEP-2023. ARE YOU ABLE TO ADVISE THE DATE OF EVENT? UNABLE TO RECALL. CAN PROVIDE THIS INFORMATION WHEN OUR SYSTEMS COME BACK UP. WHERE WAS THE ORANGE RESIDUE LOCATED? WAS IT INSIDE THE SYRINGE IN THE FLUID PATH OR OUTSIDE OF THE SYRINGE? IT IS ON THE OUTER PACKAGE OF THE SYRINGE... CAN YOU IDENTIFY THE ORANGE RESIDUE? NO. IS THE FOREIGN MATTER ABLE TO BE REMOVED OR IS IT EMBEDDED IN THE PLASTIC? UNKNOWN¿.BECAUSE WE DON¿T KNOW WHAT THE ORANGE SUBSTANCE IS, WE¿RE HESITANT TO TOUCH IT. WAS THERE ANY PATIENT INVOLVEMENT? NO. THIS WAS FOUND WHEN WE WERE UNPACKING THE BOX TO DISTRIBUTE TO THE NURSING UNITS. NEVER MADE IT OUT OF THE STORE ROOM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ORANGE RESIDUE WAS FOUND ON THE PACKAGES AND IN THE BOX OF BD LUER-LOK¿ TIP SYRINGES WHILE UNPACKING THE BOX. THIS WAS FOUND WITH 4 SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DETAIL: ORANGE RESIDUE ON 4 SYRINGES THAT WERE AT THE BOTTOM OF THE BOX. FOUND AS THE BOX WAS BEING UNPACKED TO TAKE TO UNIT. NO PREVIOUS EXPOSURE OUTSIDE THE BOX. BOX IS UNDAMAGED. UNKNOWN ORIGIN OF RESIDUE. NUMBER OF OCCURRENCES: 4.0. RESPONSE RECEIVED ON 01-SEP-2023. ARE YOU ABLE TO ADVISE THE DATE OF EVENT? UNABLE TO RECALL. CAN PROVIDE THIS INFORMATION WHEN OUR SYSTEMS COME BACK UP. WHERE WAS THE ORANGE RESIDUE LOCATED? WAS IT INSIDE THE SYRINGE IN THE FLUID PATH OR OUTSIDE OF THE SYRINGE? IT IS ON THE OUTER PACKAGE OF THE SYRINGE. CAN YOU IDENTIFY THE ORANGE RESIDUE? NO IS THE FOREIGN MATTER ABLE TO BE REMOVED OR IS IT EMBEDDED IN THE PLASTIC? UNKNOW BECAUSE WE DON¿T KNOW WHAT THE ORANGE SUBSTANCE IS, WE¿RE HESITANT TO TOUCH IT. WAS THERE ANY PATIENT INVOLVEMENT? NO. THIS WAS FOUND WHEN WE WERE UNPACKING THE BOX TO DISTRIBUTE TO THE NURSING UNITS. NEVER MADE IT OUT OF THE STORE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242326 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 3110741 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown