BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE

    MDR report key: 8654452 · Received May 30, 2019

    Report

    Report Number
    3003152976-2019-00362
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    May 15, 2019
    Report Date
    August 9, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE PHOTO WAS PROVIDED TO OUR QUALITY ENGINEER TEAM FOR EVALUATION. UPON REVIEWING THE SAMPLE PHOTO, WE WERE ABLE TO OBSERVE DAMAGE ON THE 20ML MARKING OF THE SYRINGE. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NO-CONFORMANCES RELATED TO THE REPORTED ISSUE DURING PRODUCTION OF BATCH 1902236. TEN RETAINED SAMPLES WERE USED FOR ADDITIONAL EVALUATION. VISUAL INSPECTION DID NOT REVEAL ANY DAMAGE OR DEFECTS ON THE BARRELS OF THE SYRINGE. WHILE A DIRECT ISSUE COULD NOT BE IDENTIFIED, THE DAMAGE OBSERVED WAS CONSISTENT WITH THE TRANSFER WHEELS USED TO MOVE PRODUCT WITHIN THE MANUFACTURING LINE. IT IS LIKELY THE PRODUCT BECAME JAMMED IN THE EQUIPMENT, RESULTING IN THE DAMAGE REPORTED. THOROUGH INSPECTION HAS BEEN IMPLEMENTED IN THIS MANUFACTURING LINE AND CORRECTIVE ACTION COR 526-19 (PROJECT#1875) HAS BEEN OPENED TO INVESTIGATE AND REDUCE THE OCCURRENCE OF THIS DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE ARE DENTS ON BARREL WITH A BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2) WE HAVE HAD A FURTHER OCCURRENCE OF THIS (LOT: 1902236) AND SERIOUS CONCERNS FOR PATIENT SAFETY EXIST. FURTHERMORE WE CANNOT REMOVE ALL 50ML SYRINGES FROM STOCK BUT THE LOT NUMBERS OF CONCERN ARE ALSO STILL BEING DELIVERED. IT APPEARS THAT THERE ARE TWO IDENTICAL ¿DENTS¿ AROUND THE 20MLS MARK. THE PLASTIC IS NOT SPLIT. THE SYRINGE RUNS NORMALLY UNTIL IT REACHES THE 20ML MARK AND IT APPEARS THE PLUNGER LOSES ITS SEAL OVER THE DAMAGED AREA AND AIR THEN ENTERS THE SYRINGE, CAUSING RAPID INFUSION OF MEDICATION AND THEN AIR.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 THERE ARE DENTS ON BARREL WITH A BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2). WE HAVE HAD A FURTHER OCCURRENCE OF THIS (LOT: 1902236) AND SERIOUS CONCERNS FOR PATIENT SAFETY EXIST. FURTHERMORE WE CANNOT REMOVE ALL 50ML SYRINGES FROM STOCK BUT THE LOT NUMBERS OF CONCERN ARE ALSO STILL BEING DELIVERED. IT APPEARS THAT THERE ARE TWO IDENTICAL ¿DENTS¿ AROUND THE 20MLS MARK. THE PLASTIC IS NOT SPLIT. THE SYRINGE RUNS NORMALLY UNTIL IT REACHES THE 20ML MARK AND IT APPEARS THE PLUNGER LOSES ITS SEAL OVER THE DAMAGED AREA AND AIR THEN ENTERS THE SYRINGE, CAUSING RAPID INFUSION OF MEDICATION AND THEN AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446206 BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE SYRINGE JKA BECTON DICKINSON, S.A. 1902236

    Patients

    Seq Age Sex Outcome Treatment
    1 Other