BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD - 3-PIECE SYRINGE

    MDR report key: 17037481 · Received June 1, 2023

    Report

    Report Number
    3002682307-2023-00142
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Date of Event
    January 19, 2023
    Report Date
    August 15, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 307736 AND LOT NUMBERS 2211231, 2009137, 2103153. 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. AS NEITHER PICTURE SAMPLES NOR PHYSICAL SAMPLES WERE AVAILABLE FOR THIS REPORT, TWENTY RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY; HOWEVER, UPON REVIEW, NO SIGNS OF DEFECT WERE IDENTIFIED. THE PROCESS USED TO PRINT THE SCALE CONSISTS OF HOT STAMPING, WHICH EMBEDS THE INK INTO THE SYRINGE BARREL. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED INCIDENT.

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2211231. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2027. H.4. DEVICE MANUFACTURE DATE: 07-NOV-2022. D.4. MEDICAL DEVICE LOT #: 2009137. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2025. H.4. DEVICE MANUFACTURE DATE: 02-SEP-2020. D.4. MEDICAL DEVICE LOT #: 2103153. D.4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2026. H.4. DEVICE MANUFACTURE DATE: 09-MAR-2021. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. E.1 INITIAL REPORTER PHONE #: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 41 OF THE BD EMERALD - 3-PIECE SYRINGE EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAFF FOUND MORE MISPRINTING OF SYRINGES, FOLLOWING A INTERNAL COMMUNICATIONS TO ASK STAFF TO BE VIGILANT WHEN USING THE DEVICE. THE INTERNAL COMMUNICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 41 OF THE BD EMERALD - 3-PIECE SYRINGE EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAFF FOUND MORE MISPRINTING OF SYRINGES, FOLLOWING A INTERNAL COMMUNICATIONS TO ASK STAFF TO BE VIGILANT WHEN USING THE DEVICE. THE INTERNAL COMMUNICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296272 BD EMERALD - 3-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown