BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LS 200 S/C

    MDR report key: 9197135 · Received October 16, 2019

    Report

    Report Number
    1213809-2019-01052
    Event Type
    Malfunction
    Date Received
    October 16, 2019
    Date of Event
    September 30, 2019
    Report Date
    November 14, 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

    H.6. INVESTIGATION: TWO PHOTOS AND SIX 3ML SYRINGES WERE RECEIVED AND EVALUATED. FIVE WERE IN FULLY SEALED BLISTER PACKS FROM BATCH 9002521 (P/N 309656) AND ONE WAS LOOSE. IT WAS OBSERVED ALL THE SYRINGES CONTAINED VARYING DEGREES OF ROLLED SCALES AND MISSING 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. CORRECTIVE ACTION, THE PRINTING COMPONENTS INVOLVED IN THE ROLLED SCALE WERE REPLACED. FOR INSUFFICIENT CONTAINMENT, CORRECTIVE AND PREVENTION ACTION WAS OPENED AND IMPLEMENTED. CAPA#753644.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE SYRINGE 3ML LS 200 S/C HAS BEEN FOUND EXPERIENCING SCALE MARKING ISSUES BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SYRINGES ARE MISSING THE MEASUREMENT LINES. VERBATIM: I JUST HAD A CLIENT CALL IN THAT HAS A BOX OF SYRINGE BD 3CC LUER SLIP TIP - 200'S THAT ARE MISSING THE MEASUREMENT LINES. LOT # 9002521, EXPIRY DATE 2023/12/31. THIS IS NOT THE FIRST BOX FROM THAT LOT THAT WE HAVE HAD CLIENTS CALL ABOUT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 HAS BEEN REPORTED THAT THE SYRINGE 3ML LS 200 S/C HAS BEEN FOUND EXPERIENCING SCALE MARKING ISSUES BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SYRINGES ARE MISSING THE MEASUREMENT LINES. VERBATIM: I JUST HAD A CLIENT CALL IN THAT HAS A BOX OF SYRINGE BD 3CC LUER SLIP TIP - 200'S THAT ARE MISSING THE MEASUREMENT LINES. LOT # 9002521, EXPIRY DATE 2023/12/31. THIS IS NOT THE FIRST BOX FROM THAT LOT THAT WE HAVE HAD CLIENTS CALL ABOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993280 SYRINGE 3ML LS 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9002521 30382903096566

    Patients

    Seq Age Sex Outcome Treatment
    1 Other