BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 8617309 · Received May 16, 2019

    Report

    Report Number
    3003152976-2019-00328
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    May 5, 2019
    Report Date
    June 21, 2019
    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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TWO SAMPLES WERE RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE SYRINGE BARREL WAS OBSERVED TO BE DAMAGED BETWEEN THE 15ML AND 20ML MARKING. THE BARREL IS DENTED IN THIS AREA AND THE STOPPER RIBS BECOME DISTORTED WHEN MOVED ACROSS THIS POINT, CAUSING A LEAK AS A RESULT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1902237, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL TESTING THROUGHOUT THE MANUFACTURING PROCESS ACCORDING TO PROCEDURE. THE DAMAGE NOTED IN THE PHOTO IS CONSISTENT WITH MARKINGS FROM THE TRANSFERENCE WHEELS OF THE ASSEMBLY MACHINE. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, WE DETERMINED THIS INCIDENT OCCURRED DUE TO THE BARREL JAMMING IN THE TRANSFERENCE WHEELS. CORRECTIVE ACTION (COR C-526-19 AND PROJECT#1875) HAS BEEN OPENED TO INVESTIGATE AND REDUCE THE OCCURRENCE OF THIS DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 50ML LL EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WORD FILE: DURING THE SALINE SAMPLE COLLECTION WITH THE INCRIMINATED SYRINGE, THE SEAL LET AIR PASS, AND DURING THE EXPULSION OF AIR, LEAKAGE OF THE SALINE THROUGH THE PISTON MAIL: TWO LUER LOCK SYRINGES 50 ML, REFERENCE: (B)(4). LOT: 1902237 (FOR THE SECOND), SHOWED A LEAK AT THE PISTON SEAL. THEY HAVE BEEN KEPT FOR EXPERTISE.

    Additional Manufacturer Narrative · 1

    (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 AN UNSPECIFIED NUMBER OF SYRINGE 50ML LL EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WORD FILE: DURING THE SALINE SAMPLE COLLECTION WITH THE INCRIMINATED SYRINGE, THE SEAL LET AIR PASS, AND DURING THE EXPULSION OF AIR, LEAKAGE OF THE SALINE THROUGH THE PISTON. MAIL: TWO LUER LOCK SYRINGES 50 ML, REFERENCE: 300865 LOT: 1902237 (FOR THE SECOND), SHOWED A LEAK AT THE PISTON SEAL. THEY HAVE BEEN KEPT FOR EXPERTISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407786 SYRINGE 50ML LL SYRINGE FMF BECTON DICKINSON, S.A. 1902237

    Patients

    Seq Age Sex Outcome Treatment
    1 Other