BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH NEEDLE

    MDR report key: 8505933 · Received April 11, 2019

    Report

    Report Number
    3002682307-2019-00246
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 22, 2019
    Report Date
    May 24, 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS BEEN PROVIDED WITH PHOTOS FOR 301940 LOTS 1505142, 1803120, 182153, 1803117 AND 1803130 TO INVESTIGATE FOR THIS RECORD. AFTER THE EVALUATION OF THE RETURNED PICTURE, THE WHITE PARTICLES INSIDE THE SYRINGE WERE COMPOSED BY LUBRICANT FROM THE SYRINGE BARREL. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE PARTICLES CONSIST OF AN ACCUMULATION OF "SLIP AGENT" WHICH IS USED IN THE FORMULATION AND MANUFACTURING OF THE POLYPROPYLENE SYRINGES. THE SLIP AGENT IS USED TO FACILITATE THE MOVEMENT OF THE PLUNGER ALONG THE BARREL. DURING THE MANUFACTURING PROCESS, THE LUBRICANT FORMS A MICROSCOPIC LAYER IN THE INTERNAL/EXTERNAL WALLS OF THE BARREL. WHEN THE PLUNGER IS MOVED BACKWARDS DURING THE FILLING OF THE SYRINGE, MOST OF THIS MICROSCOPE LAYER OF LUBRICANT IS DRAGGED BEHIND THE PLUNGER AND A SMALL QUANTITY REMAINS INSIDE TO ALLOW A GOOD SLIDING PERFORMANCE DURING THE INJECTION OPERATION. TOXICOLOGIC MATERIAL RISK ASSESSMENT TESTS HAVE BEEN CONDUCTED AND THEY HAVE ALL PASSED ALL ESTABLISHED CRITERIA FOR PRECLINICAL TOXICOLOGICAL SAFETY EVALUATIONS AND SHOULD NOT REPRESENT ANY RISK IF THE PRODUCT IS USED ACCORDING TO NORMAL PRACTICES. WE HAVE INITIATED THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTIONS FOR THIS ISSUE. CAPA #207816. BD HAS REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD SYRINGE¿ WITH NEEDLE IT WAS FOUND THAT WHITE FLOCCULENT FOREIGN MATTER IN BARREL. THE DEFECT WAS FOUND IN 5 BATCHES OF PRODUCTS. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IT WAS FOUND THAT WHITE FLOCCULENT FOREIGN MATTER IN BARREL. THE DEFECT WAS FOUND IN 5 BATCHES OF PRODUCTS.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1505142; MEDICAL DEVICE EXPIRATION DATE: 2020-04-30; DEVICE MANUFACTURE DATE: 2015-05-06; MEDICAL DEVICE LOT #: 1803120; MEDICAL DEVICE EXPIRATION DATE: 2023-02-28; DEVICE MANUFACTURE DATE: 2018-03-13; MEDICAL DEVICE LOT #: 1802153; MEDICAL DEVICE EXPIRATION DATE: 2023-01-31; DEVICE MANUFACTURE DATE: 2018-02-08; MEDICAL DEVICE LOT #: 1803117; MEDICAL DEVICE EXPIRATION DATE: 2023-02-28; DEVICE MANUFACTURE DATE: 2018-03-08; MEDICAL DEVICE LOT #: 1803130; MEDICAL DEVICE EXPIRATION DATE: 2020-04-30; DEVICE MANUFACTURE DATE: 2015-05-06. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD SYRINGE¿ WITH NEEDLE IT WAS FOUND THAT WHITE FLOCCULENT FOREIGN MATTER IN BARREL. THE DEFECT WAS FOUND IN 5 BATCHES OF PRODUCTS. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: IT WAS FOUND THAT WHITE FLOCCULENT FOREIGN MATTER IN BARREL. THE DEFECT WAS FOUND IN 5 BATCHES OF PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297740 BD SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other