BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8632027 · Received May 22, 2019

    Report

    Report Number
    3003152976-2019-00339
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    April 22, 2019
    Report Date
    June 17, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008650
    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 SUMMARY: 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. AS A LOT NUMBER WAS UNKNOWN FOR THIS INCIDENT, A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED AND ADDITIONAL RETAINED SAMPLES COULD NOT BE INVESTIGATED. 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. A PROJECT HAS BEEN INITIATED TO LOOK FURTHER INTO THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED WITH A BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHEN I ARRIVED IN THE ROOM, PROPOFOL FLOWED BACK INTO THE SUFENTANYL SYRINGE. IT HAS A DEFECT. MAIL: TWO LUER LOCK SYRINGES 50 ML, REFERENCE: 300865, LOT: 1902237 (FOR THE SECOND), SHOWED A LEAK AT THE PISTON SEAL." THIS IS ONE OF TWO COMPLAINTS, THE OTHER COMPLAINT IS FILED UNDER MFR# 3003152976-2019-00328

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (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 LEAKAGE OCCURRED WITH A BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "WHEN I ARRIVED IN THE ROOM, PROPOFOL FLOWED BACK INTO THE SUFENTANYL SYRINGE. IT HAS A DEFECT. MAIL: TWO LUER LOCK SYRINGES 50 ML, REFERENCE: 300865 LOT: 1902237 (FOR THE SECOND), SHOWED A LEAK AT THE PISTON SEAL." THIS IS ONE OF TWO COMPLAINTS, THE OTHER COMPLAINT IS FILED UNDER MFR# 3003152976-2019-00328.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423816 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other