BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL

    MDR report key: 10112352 · Received June 2, 2020

    Report

    Report Number
    9614033-2020-00089
    Event Type
    Malfunction
    Date Received
    June 2, 2020
    Date of Event
    May 12, 2020
    Report Date
    June 4, 2020
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096269
    PMA / PMN Number
    K980580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR SAMPLES WERE RECEIVED FOR EVALUATION. THE BATCH NUMBERS PROVIDED: 4154804, 3298116, 0054508, 2150297, AND 3212011 WERE ALL MANUFACTURED PRIOR TO THE UDI REQUIREMENTS THAT MANDATED MARKING INDIVIDUAL PACKAGING WITH EXPIRATION DATE. THESE BATCHES WERE ALL MANUFACTURED CORRECTLY PER PRODUCT DESIGN AT THAT TIME. THE MOST RECENT BATCH, #4154804, WAS EXPIRED AS OF 31 MAY 2019. THE REPORTED DEFECT WAS NOT IDENTIFIED BASED ON THE PRODUCT INFORMATION PROVIDED AND NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME. DHR WAS PERFORMED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 4154804 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. THE DHRS ARE NO LONGER AVAILABLE FOR FOLLOWING BATCH AND PRODUCT NUMBERS AS RECORDS ARE ONLY RETAINED FOR SEVEN YEARS: 3298116 - 309572; 0054508 - 309570; 2150297 - 309577; 3212011 ¿ 309581 H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BOX OF SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL HAD NO EXPIRATION DATE ON IT BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 6 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST CALLED TO INQUIRE ABOUT EXPIRATION AND DISPOSAL OF EXPIRED SYRINGES. LOT #S 3298116, 4154804, 0054508, 2150297 AND 3212011. PHARMACIST SAID THERE IS NO EXPIRATION DATE ON THE BOXES."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOX OF SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL HAD NO EXPIRATION DATE ON IT BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 6 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST CALLED TO INQUIRE ABOUT EXPIRATION AND DISPOSAL OF EXPIRED SYRINGES. LOT #S 3298116, 4154804, 0054508, 2150297 AND 3212011. PHARMACIST SAID THERE IS NO EXPIRATION DATE ON THE BOXES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571472 SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 309626 4154804 30382903096269

    Patients

    Seq Age Sex Outcome Treatment
    1 Other