BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 13723845 · Received March 10, 2022

    Report

    Report Number
    9614033-2022-00014
    Event Type
    Malfunction
    Date Received
    March 10, 2022
    Date of Event
    February 9, 2022
    Report Date
    December 28, 2022
    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
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 21-DEC-2022. H6: INVESTIGATION SUMMARY FOUR SAMPLES RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, MISSING CANNULA AND BOWED BARREL ARE OBSERVED. UNABLE TO CONFIRM NEEDLE PULLED OUT OF HUB BASED ON THE IMAGES RECEIVED. 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. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 BD PLASTIPAK¿ SYRINGES WERE FOUND CROOKED/CURVED. ADDITIONALLY, 3 SYRINGES HAD ISSUES WITH THEIR NEEDLES BREAKING FROM THE HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "SYRINGES ARE CROOKED OR CURVED (DURING THE VISIT, 3 DIFFERENT BAGS WERE OPENED, AND ALL THREE HAD CROOKED OR CURVED SYRINGES)... THE PHYSICIAN'S LAST COMPLAINT WAS THAT DURING THE APPLICATION OF VACCINE, IN MORE THAN ONE OCCASION, THE NEEDLE BROKE FROM THE PART OF THE SEAL." HOW MANY UNITS OF THE PRODUCT ARE CROOKED OR CURVED? (CROOKED/CURVED AMOUNT); A: 10 PIECES. HOW MANY TIMES DID THE NEEDLE BREAK FROM THE SEAL PART DURING APPLICATION? A: 3 TIMES. WAS THE NEEDLE USED FOR ASPIRATION OF THE VACCINE? A: YES. DID THE NEEDLE BREAK FROM THE SEAL IN THE PATIENT'S LIMB? A: NO. HAS THERE BEEN ANY HARM TO THE PATIENT/HEALTH PROFESSIONAL? (DETAIL) A: NO. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO WHAT HAPPENED (NEEDLE REMOVAL PROCEDURE, TESTS, SURGERY, MEDICATION ADMINISTRATION, ETC.)? (DETAIL) A: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 BD PLASTIPAK¿ SYRINGES WERE FOUND CROOKED/CURVED. ADDITIONALLY, 3 SYRINGES HAD ISSUES WITH THEIR NEEDLES BREAKING FROM THE HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "SYRINGES ARE CROOKED OR CURVED (DURING THE VISIT, 3 DIFFERENT BAGS WERE OPENED, AND ALL THREE HAD CROOKED OR CURVED SYRINGES)... THE PHYSICIAN'S LAST COMPLAINT WAS THAT DURING THE APPLICATION OF VACCINE, IN MORE THAN ONE OCCASION, THE NEEDLE BROKE FROM THE PART OF THE SEAL." HOW MANY UNITS OF THE PRODUCT ARE CROOKED OR CURVED? (CROOKED/CURVED AMOUNT); A: 10 PIECES. HOW MANY TIMES DID THE NEEDLE BREAK FROM THE SEAL PART DURING APPLICATION? A: 3 TIMES. WAS THE NEEDLE USED FOR ASPIRATION OF THE VACCINE? A: YES. DID THE NEEDLE BREAK FROM THE SEAL IN THE PATIENT'S LIMB? A: NO. HAS THERE BEEN ANY HARM TO THE PATIENT/HEALTH PROFESSIONAL? (DETAIL) A: NO. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO WHAT HAPPENED (NEEDLE REMOVAL PROCEDURE, TESTS, SURGERY, MEDICATION ADMINISTRATION, ETC.)? (DETAIL) A: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270439 BD PLASTIPAK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 1196131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown