BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 11868025 · Received May 22, 2021

    Report

    Report Number
    1213809-2021-00363
    Event Type
    Malfunction
    Date Received
    May 22, 2021
    Date of Event
    April 23, 2021
    Report Date
    June 24, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903009122
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 1004872. D4: MEDICAL DEVICE EXPIRATION DATE: 2025-12-31. H4: DEVICE MANUFACTURE DATE: 2021-01-04. D4: MEDICAL DEVICE LOT #: 1004871. D4: MEDICAL DEVICE EXPIRATION DATE: 2025-12-31. H4: DEVICE MANUFACTURE DATE: 2021-01-04. D4: MEDICAL DEVICE LOT #: 0174858. D4: MEDICAL DEVICE EXPIRATION DATE: 2025-06-30. H4: DEVICE MANUFACTURE DATE: 2020-06-22. D4: MEDICAL DEVICE LOT #: 0252428. D4: MEDICAL DEVICE EXPIRATION DATE: 2025-08-31. H4: DEVICE MANUFACTURE DATE: 2020-09-08. D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: INVESTIGATION SUMMARY: MULTIPLE BOXES CONTAINING A TOTAL OF NINE HUNDRED AND FORTY-THREE 10ML (P/N 300912) SYRINGES SEALED IN BLISTERPAKS WERE OBTAINED. FIVE HUNDRED AND EIGHTY-FOUR WERE FROM BATCH #0174858, ONE HUNDRED AND NINETY-SEVEN WERE FROM BATCH #1004872, AND ONE HUNDRED AND SIXTY-SEVEN WERE FROM BATCH #0252428. NO SAMPLES WERE RECEIVED FROM BATCH #1004871. ALL SAMPLES WERE VISUALLY EVALUATED. NO DEFECTS WERE FOUND AND ALL PRODUCT WAS ACCEPTABLE PER PRODUCT SPECIFICATION. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A "SMEAR" WAS FOUND INSIDE THE BD LUER-LOK¿ TIP SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "THE CUSTOMER REPORTS THE BUILDING OF BUBBLES AND SMEAR FORMATION INSIDE THE SYRINGES."

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A "SMEAR" WAS FOUND INSIDE THE BD LUER-LOK¿ TIP SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "THE CUSTOMER REPORTS THE BUILDING OF BUBBLES AND SMEAR FORMATION INSIDE THE SYRINGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764753 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 300912 UNKNOWN 30382903009122

    Patients

    Seq Age Sex Outcome Treatment
    1