BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALDTM SYRINGE WITH DETACHED NEEDLE

    MDR report key: 16935725 · Received May 15, 2023

    Report

    Report Number
    3002682307-2023-00119
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    April 19, 2023
    Report Date
    June 26, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, 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: 22-MAY-2023. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER (B)(6) AND LOT NUMBER 2012126. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO (2) PICTURE SAMPLES AND THE AFFECTED PHYSICAL SAMPLE WERE RETURNED FOR EVALUATION BY OUR INVESTIGATIVE TEAM. THROUGH EXAMINATION OF THE SAMPLE, ONE EXTRA NEEDLE COMPONENT WAS OBSERVED OUTSIDE OF THE BLISTER CAVITY AND THE PACKAGE SEAL. THIS DEFECT MOST LIKELY RESULTED FROM A MISPLACEMENT OF A NEEDLE DURING PRODUCTION. AFTERWARDS, THE NEEDLE WAS BROKEN DUE TO THE PACKAGE SEALING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD EMERALDTM SYRINGE WITH DETACHED NEEDLE THE NEEDLE PIERCED THE STERILE BARRIER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE DEALER REPORTED THAT IN THE REPRODUCTIVE MEDICINE DEPARTMENT OF THE HOSPITAL, BECAUSE THERE WERE TWO NEEDLES IN THE INJECTION NEEDLE, ONE OF WHICH WAS EXPOSED, THE DOCTOR WAS STABBED BY THE EXPOSED NEEDLE WHEN USING THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD EMERALDTM SYRINGE WITH DETACHED NEEDLE THE NEEDLE PIERCED THE STERILE BARRIER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE DEALER REPORTED THAT IN THE REPRODUCTIVE MEDICINE DEPARTMENT OF THE HOSPITAL, BECAUSE THERE WERE TWO NEEDLES IN THE INJECTION NEEDLE, ONE OF WHICH WAS EXPOSED, THE DOCTOR WAS STABBED BY THE EXPOSED NEEDLE WHEN USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474938 BD EMERALDTM SYRINGE WITH DETACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2012126

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown