BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20 ML SYRINGE WITH NEEDLE

    MDR report key: 9587179 · Received January 14, 2020

    Report

    Report Number
    3002682307-2019-00721
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    December 27, 2019
    Report Date
    February 3, 2020
    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

    H.6. INVESTIGATION: BD HAS BEEN PROVIDED WITH A SAMPLE FOR CATALOG 301948 LOT 1901180 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE SAMPLE SHOWED HIGHER AMOUNT OF SILICONE STICK AT THE UPPER SIDE INSIDE THE SYRINGE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE ORIGIN OF THE REPORTED NONCONFORMANCE CONSISTED OF SILICONE OIL. THIS SILICONE OIL IS USED TO LUBRICATE THE INNER PART OF THE BARREL AND FACILITATE THE MOVEMENT OF THE PLUNGER ROD. CORRECT PRESENCE AND QUANTITY OF SILICONE IN THE SYRINGE IS EVALUATED IN OUR ROUTINE MANUFACTURING CONTROLS. BD CONSIDERS THAT BECAUSE OF SOME TEMPORARY ISSUE IN THE SILICONIZATION PROCESS, THERE WAS AN EXCESS OF SILICONE CAUSING THE REPORTED NONCONFORMANCE. THE DEVICE HISTORY REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EXCESS LUBRICANT WAS FOUND ON SYRINGE WITH A BD¿ 20 ML SYRINGE WITH NEEDLE. THIS OCCURRED WITH 1200 SEPARATE SYRINGES PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2019, A COMPLAINT WAS RECEIVED FROM HEAD NURSE, IT WAS REPORTED THAT MATERIAL NO.301948 FOUND THE LUBRICANT ACCUMULATION ON THE FRONT OF THE SYRINGE WHEN THE DRUG WAS CONFIGURED. THE COMPLAINT INVOLVED ABOUT 1200 DISPOSABLE STERILE SYRINGES.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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 EXCESS LUBRICANT WAS FOUND ON SYRINGE WITH A BD¿ 20 ML SYRINGE WITH NEEDLE. THIS OCCURRED WITH 1200 SEPARATE SYRINGES PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ON (B)(6) 2019, A COMPLAINT WAS RECEIVED FROM HEAD NURSE, IT WAS REPORTED THAT MATERIAL NO.301948 FOUND THE LUBRICANT ACCUMULATION ON THE FRONT OF THE SYRINGE WHEN THE DRUG WAS CONFIGURED. THE COMPLAINT INVOLVED ABOUT 1200 DISPOSABLE STERILE SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52104 BD 20 ML SYRINGE WITH NEEDLE SYRINGE/NEEDLE FMF BECTON DICKINSON, S.A. 1901180

    Patients

    Seq Age Sex Outcome Treatment
    1 Other