BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 14160435 · Received April 20, 2022

    Report

    Report Number
    1911916-2022-00203
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 29, 2022
    Report Date
    May 24, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 1180460 D4: MEDICAL DEVICE EXPIRATION DATE: 2026-05-31 H4: DEVICE MANUFACTURE DATE: 2021-06-29 D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 23-MAY-2022 H6: INVESTIGATION SUMMARY IT WAS REPORTED THE CUSTOMER RECEIVED PRODUCT WITH FOREIGN MATTER, DENTED AND WITH A PRINTING DEFECT. TO AID IN THE INVESTIGATION, FORTY-THREE SAMPLES AND SIX PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY ISSUE. FORTY-TWO SAMPLES CAME WITH NO PACKAGING BLISTER AND ONE SAMPLE CAME WITH A PACKAGING BLISTER SHOWING LOT 1180460. A VISUAL INSPECTION WAS PERFORMED WITH A 10X MAGNIFIER LENS. THIRTY-ONE SAMPLES HAVE EMBEDDED DEGRADED RESIN AND TWO SAMPLES HAVE BARREL DAMAGE. OF THE REMAINING SAMPLES, ONE HAS A SCALE PRINTING IMPERFECTION AND NINE SAMPLES HAVE RUB MARKS; THESE ARE ACCEPTABLE IMPERFECTIONS. THE SIX PHOTOS PROVIDED SHOW SOME OF THE SAMPLES RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT NUMBER 1180460. 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 THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AS THE SCALE MARKING ISSUE REPORTED IS CONSIDERED AN ACCEPTABLE IMPERFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BD SYRINGE LUER-LOK¿ TIP. THIS EVENT OCCURRED 38 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM: 38 BLACK SPOTS AND STAINS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BD SYRINGE LUER-LOK¿ TIP. THIS EVENT OCCURRED 38 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM: 38 BLACK SPOTS AND STAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2718358 BD SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302830 1180460 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown