BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 12674700 · Received October 21, 2021

    Report

    Report Number
    1213809-2021-00719
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 23, 2021
    Report Date
    October 29, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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: 2021-10-18. H6: INVESTIGATION SUMMARY : THREE PHOTOS AND FIVE LOOSE 10ML SYRINGES (P/N 301029) WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. TWO SYRINGES WERE OBSERVED TO HAVE A ROUGH APPEARANCE AND POROUS PRINT NEAR THE MID-POINT OF THE GRADUATED SCALE WITH ALL MARKINGS STILL LEGIBLE. ONE SYRINGE HAD A LENGTHWISE SCRATCH EXTENDING FROM THE ZERO LINE THROUGH THE SCALE DOWN INTO THE BD LOGO, ALL GRAD LINES AFFECTED WERE MISSING LESS THAN 50% OF THEIR PRINTED SURFACE. THESE THREE SYRINGES ARE CONSIDERED ACCEPTABLE PER PRODUCT SPECIFICATION. ONE SYRINGE WAS OBSERVED TO HAVE POROUS PRINT NEAR THE MID-POINT OF THE GRADUATED SCALE HOWEVER THE 5ML NUMERAL WAS NOT LEGIBLE. ONE SYRINGE HAD MISSING PRINT ON SEVERAL GRAD LINES BETWEEN THE 6ML AND 8ML GRAD LINE, ALSO ON THE 9 NUMERALS. IN BOTH INSTANCES THE PRINT APPEARED TO HAVE BEEN SCRAPED OFF. THESE TWO SYRINGES WERE NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. IT IS POSSIBLE THAT A JAMMED COMPONENT IN THE ASSEMBLY MACHINE CAUSED SOME OF THE PRINT TO BE INADVERTENTLY REMOVED FROM THE SYRINGES BEFORE DISLODGING ITSELF. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH #0142212 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. SINCE NO SAMPLES DISPLAYING THE PLUNGER DEFECT WERE RECEIVED POTENTIAL ROOT CAUSE COULD NOT BE ESTABLISHED AND CORRECTIVE ACTIONS ARE NOT REQUIRED. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ TIP SYRINGE THERE WAS SCALE MARKING ISSUES AND THE PLUNGER ROD WAS BROKEN/DAMAGED. THE SCALE MARKING ISSUE INVOLVED 1800 DEVICES. THE DAMAGED PLUNGER EVENT INVOLVED 10 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WERE "DEFECTS FOUND ON THE 5 ML SYRINGES. THE SYRINGES HAD A DAMAGED GRADUATED SCALE MAKING THEM UNUSABLE. WITH THIS LOT WE ALSO FOUND SOME SYRINGES WITH DAMAGED PLUNGERS."

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ TIP SYRINGE THERE WAS SCALE MARKING ISSUES AND THE PLUNGER ROD WAS BROKEN/DAMAGED. THE SCALE MARKING ISSUE INVOLVED 1800 DEVICES. THE DAMAGED PLUNGER EVENT INVOLVED 10 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WERE "DEFECTS FOUND ON THE 5 ML SYRINGES. THE SYRINGES HAD A DAMAGED GRADUATED SCALE MAKING THEM UNUSABLE. WITH THIS LOT WE ALSO FOUND SOME SYRINGES WITH DAMAGED PLUNGERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575347 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0142212

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown