BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 3ML SYRINGE SLIP TIP

    MDR report key: 9213649 · Received October 21, 2019

    Report

    Report Number
    1213809-2019-01057
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    October 4, 2019
    Report Date
    December 18, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096566
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TWO PHOTOS WERE RECEIVED AND EVALUATED. ONE PHOTO DISPLAYED AN OPENED BLISTER PACK FROM BATCH 9002521 (P/N309656). ONE PHOTO DISPLAYED TWO LOOSE 3ML SYRINGES WITH VARYING DEGREES OF MISSING AND ROLLED PRINT AND WERE REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT IS ASSOCIATED WITH THE PRINTING PROCESS. IT IS LIKELY A PRINTING COMPONENT GRADUALLY SLIPPED OUT OF ADJUSTMENT CAUSING THE PRINT TO BE APPLIED ON THE INCORRECT POSITION ON THE BARREL. THIS IS CONSISTENT WITH THE VARIANCE OF THE MISSING SCALE. THE POTENTIAL ROOT CAUSE FOR THE PRODUCT BEING DISTRIBUTED IS ASSOCIATED WITH INSUFFICIENT CONTAINMENT. THE MISSING PRINT WAS DISCOVERED DURING MANUFACTURING AND CONTAINMENT ACTIONS WERE ADMINISTERED BUT DEFECTIVE PRODUCT WAS STILL PACKAGED AND DISTRIBUTED. THE PRINTING COMPONENTS INVOLVED IN THE ROLLED SCALE WERE REPLACED 10/14/2019. FOR INSUFFICIENT CONTAINMENT, CORRECTIVE AND PREVENTIVE ACTION, CAPA#753644, WAS OPENED AND IMPLEMENTED 8/26/2019. DHR WAS PERFORMED AND ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT AND A QUALITY NOTIFICATION RELATED TO THE COMPLAINT DEFECT WAS ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ 3ML SYRINGE SLIP TIP IS MISSING MEASUREMENT LINES. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309656, BATCH NO.: 9002521. IT WAS REPORTED THAT THE SYRINGES ARE MISSING THE MEASUREMENT LINES. VERBATIM: WE JUST HAD ANOTHER CLIENT WANTING TO RETURN SYRINGES FROM THE SAME LOT AND EXPIRY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ 3ML SYRINGE SLIP TIP IS MISSING MEASUREMENT LINES. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309656 BATCH NO.: 9002521. IT WAS REPORTED THAT THE SYRINGES ARE MISSING THE MEASUREMENT LINES. "VERBATIM: WE JUST HAD ANOTHER CLIENT WANTING TO RETURN SYRINGES FROM THE SAME LOT AND EXPIRY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010873 BD 3ML SYRINGE SLIP TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9002521 30382903096566

    Patients

    Seq Age Sex Outcome Treatment
    1 Other