BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 14674179 · Received June 13, 2022

    Report

    Report Number
    3003152976-2022-00263
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Date of Event
    January 1, 2022
    Report Date
    June 14, 2022
    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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2201033, MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026, DEVICE MANUFACTURE DATE: 12-JAN-2022. MEDICAL DEVICE LOT #: 2112020, MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2026, DEVICE MANUFACTURE DATE: 09-DEC-2021. 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

    INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOTS 2201033 AND LOT 2112020, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF THE EACH LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS INSPECTED, NO MOISTURE ON THE PLUNGER OR OTHER FOREIGN PARTICLES WERE OBSERVED ON ANY OF THE DEVICES. BASED ON THE DESCRIPTION PROVIDED, THE ALLEGED MOISTURE MATCHES THE DESCRIPTION OF THE SILICONE USED IN THIS PRODUCT. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER, RESULTS FOR BOTH LOT 2201033 AND LOT 2112020 WERE REVIEWED AND FOUND TO BE WITHIN SPECIFICATION. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. BASED ON THE AVAILABLE INFORMATION, WE ARE NOT ABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE EACH FROM LOTS 2201033 AND 2112020 HAD MOISTURE ON THEIR PLUNGER STOPPERS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STAFF NURSE HAS HIGHLIGHTED THAT SOME OF BD PLASTIPAK 50ML HAS MOISTURE ON THE BLACK PLUNGER PART OF THE SYRINGE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE EACH FROM LOTS 2201033 AND 2112020 HAD MOISTURE ON THEIR PLUNGER STOPPERS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STAFF NURSE HAS HIGHLIGHTED THAT SOME OF BD PLASTIPAK 50ML HAS MOISTURE ON THE BLACK PLUNGER PART OF THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248410 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown