BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 15089264 · Received July 22, 2022

    Report

    Report Number
    3003152976-2022-00330
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    May 26, 2022
    Report Date
    August 29, 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

    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

    H.6. INVESTIGATION SUMMARY: NO SAMPLES OR PICTURES HAVE BEEN RECEIVED TO PERFORM INVESTIGATION. CUSTOMER REPORTS DEFECTS IN THE SCALE OF THE SYRINGES, SOME SYRINGES HAVE NO MARKINGS AND IN OTHER DEVICES THE SCALE IS CLEAR. COMPLAINT INVOLVES A 50LL SYRINGE WITH REFERENCE (B)(4) AND LOT NUMBER 2203076. SAMPLES FROM THE SAME LOT (2203076) AVAILABE IN PLANT HAVE BEEN INSPECTED FINDING THE SCALE IS NOT PRINTED AND IN SOME DEVICES THE INK IS CLEAR. DHR FROM LOT 2203076 HAS BEEN REVIEWED NOT FINDING ANY DEVIATION REGARDING THE ALLEGED DEFECT. DAILY INCIDENCE REPORT SHOWS AN INCIDENT WHERE PADS FROM THE MARKING MACHINE NEEDED TO BE CHANGE. THIS ISSUE CAN BE RELATED TO THE DEFECT NOTICED BY CUSTOMER. ACCORDING TO INSPECTION PLAN PROCEDURE JG-500, 200 UNITS ARE INSPECTED EVERY 2 PALLETS BY QUALITY CONTROL TEAM. IN ADDITION, FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED BY OPERATOR AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES: VISUAL AND FUNCTIONAL INSPECTION ALONG MOLDING, MARKING, ASSEMBLY AND PRIMARY AND SECONDARY PACKAGING. SINCE AN ANNOTATION WAS FOUND RELATED TO THE PADS OF THE MARKING MACHINE, THE ROOT CAUSE OF THE NON-CONFORMANCE CAN BE RELATED WITH A MISALIGNMENT BETWEEN THE BARREL AND THE MARKING MACHINE PADS IN THE MOMENT OF SCALE TRANSFERENCE. ONCE THE FAILURE WAS DETECTED, IT WAS IMMEDIATELY CORRECTED BY THE MECHANICAL TEAM. BASED ON ALL THE PREVENTIVE MEASURES AND OUR STRINGENT IN ¿PROCESS INSPECTION PLAN, WE ARE CERTAIN THAT THIS SHOULD BE AN ISOLATED ISSUE AND ANY RECURRENCE IS REALLY UNLIKELY BASED ON NO QUALITY NOTIFICATION WAS OPENED DURING MANUFACTURING PROCESS OF THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE THAT THERE WERE NO MARKINGS ON SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REMOVING SYRINGES FROM THE BOX IN THE STORE ROOM AND NOTICED THAT THERE ARE NO MARKINGS ALONG THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE THAT THERE WERE NO MARKINGS ON SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REMOVING SYRINGES FROM THE BOX IN THE STORE ROOM AND NOTICED THAT THERE ARE NO MARKINGS ALONG THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722708 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2203076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown