BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK¿ TIP

    MDR report key: 14940728 · Received July 6, 2022

    Report

    Report Number
    1213809-2022-00368
    Event Type
    Malfunction
    Date Received
    July 6, 2022
    Date of Event
    June 6, 2022
    Report Date
    July 14, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096450
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 27-JUN-2022. H6: INVESTIGATION SUMMARY: ONE SAMPLE AND TWO PHOTOS OF A 10ML LUER-LOCK SYRINGE (P/N 309645) WERE RECEIVED AND EVALUATED. THE SAMPLE HAS A CRACK IN THE BARREL MEASURING 11/8 INCH LONG STARTING ¼ INCH FROM THE ROOF OF THE BARREL. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE CRACKED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1113346. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD 10ML SYRINGE LUER-LOK¿ TIP PRODUCT LEAKED OUT A SPLIT/CRACK ON THE SIDE OF TWO SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE: (B)(6) 2022 COMPLAINT NUMBER: (B)(4). ITEM NUMBER: 308-309645 ITEM DESCRIPTION: 10ML LL STER SYRINGE W/ 20GX1.5¿? NDL REG INCIDENT DESCRIPTION: AS PER CS, THIS CUSTOMER ADVISED THAT THE BELOW SYRINGES APPEAR TO HAVE A SPLIT/CRACK IN THE SIDES. WHEN PUSHING MEDICATION THROUGH THE SYRINGE PRODUCT LEAKS OUT THE SIDE. THIS HAS HAPPEN WITH 2 DIFFERENT SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD 10ML SYRINGE LUER-LOK¿ TIP PRODUCT LEAKED OUT A SPLIT/CRACK ON THE SIDE OF TWO SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE: 06/06/2022, COMPLAINT NUMBER: (B)(4), ITEM NUMBER: 308-309645, ITEM DESCRIPTION: 10ML LL STER SYRINGE W/ 20GX1.5¿? NDL REG. INCIDENT DESCRIPTION: AS PER CS, THIS CUSTOMER ADVISED THAT THE BELOW SYRINGES APPEAR TO HAVE A SPLIT/CRACK IN THE SIDES. WHEN PUSHING MEDICATION THROUGH THE SYRINGE PRODUCT LEAKS OUT THE SIDE. THIS HAS HAPPEN WITH 2 DIFFERENT SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966408 BD 10ML SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309645 1113346 30382903096450

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown