BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERALD¿ SYRINGES

    MDR report key: 17114437 · Received June 12, 2023

    Report

    Report Number
    3002682307-2023-00154
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    May 19, 2023
    Report Date
    September 15, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2301118. D4. MEDICAL DEVICE EXPIRATION DATE: 31DEC2027. H4. DEVICE MANUFACTURE DATE: 27DEC2022. D4. MEDICAL DEVICE LOT #: 2211171. D4. MEDICAL DEVICE EXPIRATION DATE: 31OCT2027. H4. DEVICE MANUFACTURE DATE: 07NOV2022. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 307731 AND LOT NUMBERS 2211171 AND 2301118. 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 SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY (20) RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR REVIEW; HOWEVER, THE RETAINED SAMPLES DID NOT DISPLAY ANY SIGNS OF DEFECT. IT IS POSSIBLE THAT THE REPORTED INCIDENT RESULTED FROM A NON-EXISTENT CUT IN THE UNITARY BLISTER PACKAGES; HOWEVER, THE PERFORATION CUT WAS CLEARLY SEEN ON ALL OF THE RETAINED SAMPLE PACKAGES AND WHEN TESTING WAS PERFORMED, NO PACKAGE DAMAGE RESULTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACKAGING UNITS OF 20 BD EMERALD¿ SYRINGES HAD PACKAGING ISSUES LEAVING PAPER SHARDS AND COMPROMISING STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "QUALITY PROBLEM PRE-CUT PACKAGING THAT TEARS OFF - DISINFECTION OF SYRINGES 20 DIFFERENT SYRINGES LOTS ".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACKAGING UNITS OF 20 BD EMERALD¿ SYRINGES HAD PACKAGING ISSUES LEAVING PAPER SHARDS AND COMPROMISING STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "QUALITY PROBLEM PRE-CUT PACKAGING THAT TEARS OFF - DISINFECTION OF SYRINGES 20 DIFFERENT SYRINGES LOTS "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172130 EMERALD¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown