BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 15486856 · Received September 26, 2022

    Report

    Report Number
    9614033-2022-00076
    Event Type
    Malfunction
    Date Received
    September 26, 2022
    Date of Event
    August 10, 2022
    Report Date
    October 3, 2022
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    07501073025530
    PMA / PMN Number
    K151766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5. IT WAS REPORTED THAT 2 BD PLASTIPAK¿ SYRINGE HAD DIFFICULT PLUNGER MOVEMENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: TWO PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, PRODUCT LABEL INFORMATION CATALOG 302553, BATCH NUMBER 7230949 IS DISPLAYED, THE PRODUCT IS EXPIRED. NO OTHER DEFECTS OR ISSUES CAN BE OBSERVED, THEREFORE THIS INCIDENT IS NOT CONFIRMED. THE SAMPLES HAVE ALREADY PASSED THEIR EXPIRATION DATE, THEREFORE BD DOES NOT GUARANTEE THAT THE PRODUCT PRESENTS ANY ALTERATION OR MEETING SPECIFICATION. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ SYRINGE HAD DIFFICULT PLUNGER MOVEMENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "CYLINDER MADE OF MEDICAL GRADE MATERIAL, WHICH FITS PERFECTLY INSIDE THE BARREL AND IS EASILY MOVED MANUALLY BOTH INSIDE IT. ALTHOUGH THE PLUNGER MOVES, IT DOES NOT MOVE EASILY. IT MUST BE TAKEN INTO ACCOUNT THAT, FOR A REPETITIVE ACTION, THE USER COULD HAVE PAIN AND/OR INJURY, IN ADDITION TO INCURRING AN ADVERSE EFFECT ON THE USE WITH THE PATIENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ SYRINGE HAD DIFFICULT PLUNGER MOVEMENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "CYLINDER MADE OF MEDICAL GRADE MATERIAL, WHICH FITS PERFECTLY INSIDE THE BARREL AND IS EASILY MOVED MANUALLY BOTH INSIDE IT. ALTHOUGH THE PLUNGER MOVES, IT DOES NOT MOVE EASILY. IT MUST BE TAKEN INTO ACCOUNT THAT, FOR A REPETITIVE ACTION, THE USER COULD HAVE PAIN AND/OR INJURY, IN ADDITION TO INCURRING AN ADVERSE EFFECT ON THE USE WITH THE PATIENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE HAD DIFFICULT PLUNGER MOVEMENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "CYLINDER MADE OF MEDICAL GRADE MATERIAL, WHICH FITS PERFECTLY INSIDE THE BARREL AND IS EASILY MOVED MANUALLY BOTH INSIDE IT. ALTHOUGH THE PLUNGER MOVES, IT DOES NOT MOVE EASILY. IT MUST BE TAKEN INTO ACCOUNT THAT, FOR A REPETITIVE ACTION, THE USER COULD HAVE PAIN AND/OR INJURY, IN ADDITION TO INCURRING AN ADVERSE EFFECT ON THE USE WITH THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768290 BD PLASTIPAK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 7230949 07501073025530

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown