BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ 1-ML SYRINGE

    MDR report key: 17200360 · Received June 26, 2023

    Report

    Report Number
    1213809-2023-00666
    Event Type
    Malfunction
    Date Received
    June 26, 2023
    Date of Event
    May 10, 2023
    Report Date
    June 29, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 28-JUN-2023. H6: INVESTIGATION SUMMARY ONE SAMPLE AND SIX PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT THE STOPPER IN THE SYRINGE WAS JAMMED BETWEEN THE BARREL AND THE PLUNGER ROD. POTENTIAL ROOT CAUSE FOR THE STOPPER JAMMED DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ 1-ML SYRINGE THE STOPPER WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2023, AN ANNUAL RETAINS EXAM AND COMPONENT EXAMINATION WAS PERFORMED IN XXX ON ITEM 8148200388. THE RUBBER STOPPER OF THE SYRINGE APPEARED TO BE MELTED/DEFORMED (SYRINGE LOT: 9092992; SYRINGE CATALOG NUMBER: 309628) IN ONE CARTON. THERE WAS A TOTAL OF 120 RETAIN SAMPLES INSPECTED WITH ONE KIT AFFECTED BY THIS DEFECT. AFFECTED ITEMS WERE SEGREGATED FROM THE REST OF LOT AND MARKED FOR OBSERVATION. THIS OBSERVATION IS NOT RELATED TO A PRODUCT COMPLAINT REPORTED. AS THIS IS DRUG PRODUCT COMPONENT, THIS WAS NOT USED IN A MANUFACTURING PROCESS. THE RAW MATERIAL WAS SHIPPED FROM BD TO SHARP.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ 1-ML SYRINGE THE STOPPER WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2023, AN ANNUAL RETAINS EXAM AND COMPONENT EXAMINATION WAS PERFORMED ON ITEM 8148200388. THE RUBBER STOPPER OF THE SYRINGE APPEARED TO BE MELTED/DEFORMED (SYRINGE LOT: 9092992; SYRINGE CATALOG NUMBER: 309628) IN ONE CARTON. THERE WAS A TOTAL OF 120 RETAIN SAMPLES INSPECTED WITH ONE KIT AFFECTED BY THIS DEFECT. AFFECTED ITEMS WERE SEGREGATED FROM THE REST OF LOT AND MARKED FOR OBSERVATION. THIS OBSERVATION IS NOT RELATED TO A PRODUCT COMPLAINT REPORTED. AS THIS IS DRUG PRODUCT COMPONENT, THIS WAS NOT USED IN A MANUFACTURING PROCESS. THE RAW MATERIAL WAS SHIPPED FROM BD TO SHARP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841056 BD LUER-LOK¿ 1-ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 9092992 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown