BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML 29GA 12.7MM BLISTER 200BX

    MDR report key: 10182517 · Received June 22, 2020

    Report

    Report Number
    1920898-2020-00720
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Date of Event
    June 2, 2020
    Report Date
    July 10, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF DRAWINGS OF BD PRODUCT PACKAGING. CUSTOMER STATES THAT FOR BD MICRO-FINE¿ + THE OUTER LABELS AND FOR ALL MODELS SHOWS ULTRA-FINE¿. THIS ISSUE WAS INVESTIGATED UNDER SITUATION ANALYSIS BDDC-20-3844-SA. AS PER THE SITUATION ANALYSIS, THE BRANDING ON THE SHIPPER BOX WAS MODIFIED TO ULTRA-FINE+ INSTEAD OF MICRO-FINE+ ON REVISION 7 OF THE DRAWING, VIA ECR/O 500000142032. THIS CHANGE WAS EFFECTIVE ON 27 SEPTEMBER 2019. THE MANUFACTURED PRODUCTS SINCE THIS DATE HAVE BEEN PACKED WITH THE WRONG BRANDING. NO OTHER LEVEL OF PACKAGING WERE AFFECTED/MODIFIED. ASSOCIATED CAPA 474644 WAS ALSO INITIATED FOR THIS ISSUE AND FOUND THE FOLLOWING POTENTIAL ROOT CAUSES: 1. NO GRAPHICS QUALITY PROCEDURES. 2. NO REDLINE FILES PROVIDED. 3. NO VERIFICATION TOOLS TO CONFIRM ACCURACY OF GRAPHIC UPDATES. 4. LABELING REVIEW PROCEDURE, CP50086, NEEDS CLARIFICATION ON WHAT NEEDS TO BE CHECKED WHEN UPDATING GRAPHICS. PROPOSED CORRECTIONS FOR THIS ISSUE INCLUDE THE FOLLOWING: CORRECTION TO IMPACTED SKU¿S PACKAGING DRAWING, AS APPLICABLE, TO ALIGN WITH BRANDING REQUIREMENTS WILL BE ADDRESSED VIA ACR DC-2020-0066 UNABLE TO PERFORM DHR CHECK FOR LABEL INFORMATION INCORRECT DUE TO UNKNOWN LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1ML 29GA 12.7MM BLISTER 200BX HAD THE INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "¿HI, WE RECEIVED BELOW COMMENT ON THIS SUBMISSION. FOR BD MICRO-FINE¿ + THE OUTER LABELS FOR ALL MODELS SHOWS ULTRA-FINE¿.¿

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 1ML 29GA 12.7MM BLISTER 200BX HAD THE INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "¿HI, WE RECEIVED BELOW COMMENT ON THIS SUBMISSION. FOR BD MICRO-FINE¿ + THE OUTER LABELS FOR ALL MODELS SHOWS ULTRA-FINE¿¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641605 SYRINGE 1ML 29GA 12.7MM BLISTER 200BX SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other