BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10112499 · Received June 2, 2020

    Report

    Report Number
    9614033-2020-00090
    Event Type
    Malfunction
    Date Received
    June 2, 2020
    Date of Event
    May 13, 2020
    Report Date
    July 7, 2020
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: PHOTOS RECEIVED FOR INVESTIGATION. UPON OBSERVATION, THE STOPPER IS INCORRECTLY ASSEMBLED. THE POORLY ASSEMBLED STOPPER IS DUE TO POOR ALIGNMENT OF PLUNGER TIMING. THESE DEFECTS CAN BE GENERATED DURING THE MANUFACTURING PROCESS, HOWEVER THERE IS A QUALITY ACCEPTANCE LEVEL (AQL) TO ASSESS THE AMOUNT OF DEFECTIVES THAT MAY BE PRESENT TO DICTATE THE CONFORMITY OF THE PRODUCT, BASED ON THE QUANTITY OF PART REPORTED IS LOCATED WITHIN AQL. ACCORDING TO WHAT WAS ANALYZED BOTH ON THE FLOOR AND IN DOCUMENTS, THE DEFECT CAN BE CONFIRMED. DUE TO THE POSSIBILITY OF BEING A SPECIFIC CASE, AN ACTION PLAN IS MADE TO INFORM THE STAFF OF THE OCCURRENCE TO FOCUS ON ADJUSTMENTS MADE DURING MANUFACTURING. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STOPPER IN THE SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL WAS MISALIGNED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "WE HAVE RECEIVED A COMPLAINT FROM ONE OF OUR CUSTOMER WHERE IT WAS DETECTED THAT ONE OF THE SYRINGES HAS THE STOPPER IS NOT PERFECTLY POSITIONED."

    Additional Manufacturer Narrative · 1

    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 STOPPER IN THE SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL WAS MISALIGNED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "WE HAVE RECEIVED A COMPLAINT FROM ONE OF OUR CUSTOMER WHERE IT WAS DETECTED THAT ONE OF THE SYRINGES HAS THE STOPPER IS NOT PERFECTLY POSITIONED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571558 SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL SYRINGE FMF BECTON DICKINSON DE MEXICO 8290699

    Patients

    Seq Age Sex Outcome Treatment
    1 Other