BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA

    MDR report key: 8654527 · Received May 30, 2019

    Report

    Report Number
    3002682307-2019-00333
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    May 15, 2019
    Report Date
    June 18, 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 WAS PROVIDED WITH A PHOTO AND SAMPLE FOR CATALOG 301942 LOT 1810132 TO INVESTIGATE FOR THIS RECORD. VISUAL INSPECTION OF THE RETURNED SAMPLE PRESENTED THE BARREL WALL BROKEN. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. AFTER ANALYZING THE RETURNED SAMPLE AND DISCUSSING WITH OUR MANUFACTURING TECHNICIANS IN CHARGE OF THESE PRODUCT LINES, BD HAS CONCLUDED THAT THE BROKEN BARREL WAS PRODUCED IN THE PRIMARY PACKAGING MACHINE, IN THE SYRINGE FEEDER STATION, DUE TO AN INCORRECT ALIGNMENT OF THE SYRINGE PRODUCED THE RUPTURE OF THE BARREL. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BARREL WAS CRACKED AND AFFECTED FLOW WITH A BD SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA. THIS OCCURRED ON 5 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: DURING USING, IT WAS FOUND THAT THE BARREL CRACKED AND THE GAS-TIGHTNESS WAS AFFECTED.

    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 THE BARREL WAS CRACKED AND AFFECTED FLOW WITH A BD SYRINGE S2 5 ML 22 GA 1-1/4 IN BD (B)(6). THIS OCCURRED ON 5 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: DURING USING, IT WAS FOUND THAT THE BARREL CRACKED AND THE GAS-TIGHTNESS WAS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446424 BD SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1810132

    Patients

    Seq Age Sex Outcome Treatment
    1 Other