BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 16261849 · Received January 29, 2023

    Report

    Report Number
    1911916-2023-00041
    Event Type
    Malfunction
    Date Received
    January 29, 2023
    Date of Event
    January 11, 2023
    Report Date
    February 10, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 09FEB2023 . H6: INVESTIGATION SUMMARY IT WAS REPORTED THERE WAS A SMALL FLAKE IN A 50ML SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. FIRST, WITH THE NAKED EYE AND THEN WITH 10X MAGNIFICATION. NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PHOTO PROVIDED SHOWS A SYRINGE WITH NO PACKAGING BLISTER. THE SYRINGE HAS DISCOLORATION RIGHT ABOVE THE STOPPER. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 2243320. 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 THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED BUT, SINCE THE SAMPLE RECEIVED HAD NO FOREIGN MATTER, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 A FOREIGN FLAKE WAS FOUND ON THE BD LUER-LOK¿ TIP SYRINGE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE IN IV ROOM, PEDIATRIC IV TECHNICIAN FOUND A SMALL FLAKE IN A 50ML IV SYRINGE. THE FLAKE MOVED WHEN PLUNGER WAS MOVED IN AND OUT. IT WAS BETWEEN THE HUB AND THE PLUNGER BUT NOT IN AREA WHERE FLUID WOULD BE DRAWN UP. IV TECH ESCALATED IT TO INTERNAL DEPARTMENTS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FOREIGN FLAKE WAS FOUND ON THE BD LUER-LOK¿ TIP SYRINGE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE IN IV ROOM, PEDIATRIC IV TECHNICIAN FOUND A SMALL FLAKE IN A 50ML IV SYRINGE. THE FLAKE MOVED WHEN PLUNGER WAS MOVED IN AND OUT. IT WAS BETWEEN THE HUB AND THE PLUNGER BUT NOT IN AREA WHERE FLUID WOULD BE DRAWN UP. IV TECH ESCALATED IT TO INTERNAL DEPARTMENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15143 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2243320 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown