BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 10269452 · Received July 14, 2020

    Report

    Report Number
    3003152976-2020-00303
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    June 22, 2020
    Report Date
    July 29, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL? YES. D.10 RETURNED TO MANUFACTURER ON: 2020-06-30. H.6. INVESTIGATION SUMMARY: FOUR SAMPLES AND ONE PHOTO WERE RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE RETURNED PRODUCT, A FOREIGN MATTER WAS OBSERVED ON THE SYRINGE. USING MAGNIFICATION, THE MATTER WAS IDENTIFIED TO BE BURNT POLYPROPYLENE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2003248, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. PRODUCT IS INSPECTED THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, THIS MALFUNCTION WAS DETERMINED TO HAVE OCCURRED AS A RESULT OF A FAILURE IN THE GAS EXPULSION DURING THE MOLDING PROCESS IN THE INJECTION MACHINE. AS A RESULT OF THE FAILURE, POLYPROPYLENE PARTICLES GENERATE AND CAN BECOME EMBEDDED IN THE BARREL MOLDING. INJECTION MACHINES ARE RAN BEFORE USE TO CLEAR ANY LOOSE PARTICLES AND WE PERFORM ROUTINE CLEANINGS ACCORDING TO PROCEDURE. BASED ON THE PREVENTIVE MEASURES IN PLACE AND THE CURRENT INSPECTION PROCESS, THIS IS BELIEVED TO BE AN ISOLATED ISSUE WITH AN UNLIKELY RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE'S PACKAGING HAD BROWN STREAKS IN IT THAT WERE FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "ALSO THE CUSTOMER SAYS THAT THERE ARE BROWN STREAKS INSIDE THE SYRINGE. THE CUSTOMER ORDERED 11 BOXES (660 SYRINGES) AND THE PROBLEM OCCURRED ON A FEW ONLY."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE'S PACKAGING HAD BROWN STREAKS IN IT THAT WERE FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "ALSO THE CUSTOMER SAYS THAT THERE ARE BROWN STREAKS INSIDE THE SYRINGE. THE CUSTOMER ORDERED 11 BOXES (660 SYRINGES) AND THE PROBLEM OCCURRED ON A FEW ONLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733055 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2003248

    Patients

    Seq Age Sex Outcome Treatment
    1 Other