BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD SYRINGE

    MDR report key: 9866485 · Received March 23, 2020

    Report

    Report Number
    3002682307-2020-00103
    Event Type
    Malfunction
    Date Received
    March 23, 2020
    Date of Event
    March 2, 2020
    Report Date
    April 3, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 1905197 & 1905203. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO FURTHER INVESTIGATE THIS INCIDENT, THREE PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON REVIEW OF THE RETURNED SAMPLE BELONGING TO LOT NUMBER 1905197, THE SCALE MARKINGS WERE OBSERVED TO BE LOPSIDED A FEW DEGREES TO THE RIGHT. UPON REVIEW OF THE RETURNED SAMPLE BELONGING TO LOT NUMBER 1905203, THE SCALE MARKINGS WERE ALSO OBSERVED LOPSIDED TO THE RIGHT. A SAMPLE WAS ALSO RETURNED FOR LOT NUMBER 1809398, WHICH REVEALED NO SCALE DEFECTS, AS NOTED BY THE CUSTOMER. IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED FROM A MISALIGNMENT IN THE BARREL PRINTING EQUIPMENT. BASED ON THE CURRENT INSPECTION PROCESSES IN PLACE, IT IS BELIEVED THAT THIS INCIDENT HAS AN UNLIKELY RECURRENCE. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS OF SIGNS OF THIS POTENTIAL DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD EMERALD¿ SYRINGES FROM LOTS 1905197 AND 1905203 HAD MISALIGNED SCALE MARKINGS. WHEN A SYRINGE WAS PLACED IN THE "SYRINGE PROTECTION/GUARD", THE SCALE ON IT COULD NO LONGER BE SEEN THROUGH THE WINDOW OF THE SYRINGE GUARD/SHIELD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE ARE TWO LOT-NUMBERS THAT NO LONGER WORKS IN THE ¿SYRINGEPROTECTION/GUARD¿. THEY HAVEN´T USED THE SYRINGES BUT WHEN THEY PUT THE SYRINGE IN THE ¿SYRINGEPROTECTION/GUARD¿ THEY CAN NO LONGER SEE THE SCALE THROUGH THE WINDOW OF THIS SYRINGEGUARD/SHIELD. THEY THOUGHT THERE WERE SOMETHING WRONG WITH THE SYRINGESHIELD AND CONTACTED THAT COMPANY FIRST, BUT THERE WERE NO CHANGE ON THEIR PRODUCT. THEN YESTERDAY, (B)(6), THEY UNDERSTOOD THERE MUST BE SOMETHING WRONG WITH THE SYRINGE (EMERALD)." "THE CUSTOMER HAVE DISCOVERED THAT THE PRINT ON THE SYRINGE ARE NOT ON THE SAME PLACE AS BEFORE. THE CUSTOMER USE LEAD SHIELD. AND WITH THIS BATCH THEY ARE NOT ABLE TO SEE THE PRINTED SCALE IN THE WINDOW OF THE SHIELD."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1905197. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-05-06. MEDICAL DEVICE LOT #: 1905203. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-05-06. 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 · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD EMERALD¿ SYRINGES FROM LOTS 1905197 AND 1905203 HAD MISALIGNED SCALE MARKINGS. WHEN A SYRINGE WAS PLACED IN THE "SYRINGE PROTECTION/GUARD", THE SCALE ON IT COULD NO LONGER BE SEEN THROUGH THE WINDOW OF THE SYRINGE GUARD/SHIELD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE ARE TWO LOT-NUMBERS THAT NO LONGER WORKS IN THE ¿SYRINGEPROTECTION/GUARD¿. THEY HAVEN´T USED THE SYRINGES BUT WHEN THEY PUT THE SYRINGE IN THE ¿SYRINGEPROTECTION/GUARD¿ THEY CAN NO LONGER SEE THE SCALE THROUGH THE WINDOW OF THIS SYRINGEGUARD/SHIELD. THEY THOUGHT THERE WERE SOMETHING WRONG WITH THE SYRINGESHIELD AND CONTACTED THAT COMPANY FIRST, BUT THERE WERE NO CHANGE ON THEIR PRODUCT. THEN YESTERDAY, 2 MARCH, THEY UNDERSTOOD THERE MUST BE SOMETHING WRONG WITH THE SYRINGE (EMERALD)." "THE CUSTOMER HAVE DISCOVERED THAT THE PRINT ON THE SYRINGE ARE NOT ON THE SAME PLACE AS BEFORE. THE CUSTOMER USE LEAD SHIELD. AND WITH THIS BATCH THEY ARE NOT ABLE TO SEE THE PRINTED SCALE IN THE WINDOW OF THE SHIELD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333915 BD EMERALD SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other