BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH NEEDLE

    MDR report key: 8179336 · Received December 19, 2018

    Report

    Report Number
    3002682307-2018-00324
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    December 5, 2018
    Report Date
    January 8, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903019434
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT A BD 5ML SYRINGE WITH 22GA 1-1/2IN NEEDLE HAD A CRACKED BARREL AND LEAKED SOLUTION. THIS OCCURRED ON 5 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. INVESTIGATION SUMMARY: DHR:WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. SYRINGES WERE PACKAGED IN MACHINE Nº2024 (MARCH 7TH ¿ 8TH, 2018). SYRINGES WERE ASSEMBLED IN LOT #8064839. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8065743, #8058723, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8065747, #8058728, #8050851, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE BEEN PROVIDED WITH A PICTURE OF THE AFFECTED SAMPLE. VISUAL INSPECTION OF THE PHOTO PRESENTED THE BARREL BROKEN. THAT CONFIRMED THE REPORTED ISSUE. CONCLUSION(S): THE MATERIAL USED TO MANUFACTURE DISCARDIT SYRINGES HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. THE ASSEMBLING MACHINES HAVE AN ON-LINE DETECTION SYSTEM THAT INSPECTS 100 % THE SYRINGES, REJECTING AUTOMATICALLY THE SYRINGES WITH BROKEN PARTS. BASED ON THIS FACT, AND AFTER ANALYZING THE RETURNED PICTURE OF BARREL CRACK, WE THINK THAT CRACK COULD OCCUR BECAUSE OF SOME STRONG CONDITION DURING HANDLING OR TRANSPORT OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD 5ML SYRINGE WITH 22GA 1-1/2IN NEEDLE HAD A CRACKED BARREL AND LEAKED SOLUTION. THIS OCCURRED ON 5 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    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 A BD 5ML SYRINGE WITH 22GA 1-1/2IN NEEDLE HAD A CRACKED BARREL AND LEAKED SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017229 BD¿ SYRINGE WITH NEEDLE BD 5ML SYRINGE WITH 22GA 1-1/2IN NEEDLE FMI BECTON DICKINSON, S.A. 1803124 00382903019434

    Patients

    Seq Age Sex Outcome Treatment
    1 Other