BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9540849 · Received January 2, 2020

    Report

    Report Number
    3002682307-2019-00701
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 5, 2019
    Report Date
    December 13, 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 · 1

    INVESTIGATION SUMMARY: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 301942 LOT 1811192 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. BD CONCLUDES THAT THE CAUSE OF THE PROBLEM COULD BE PRODUCED BECAUSE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INVESTIGATION CONCLUSION: BASED ON THE CUSTOMER FEEDBACK OF THE ISSUE, BD CONCLUDES THAT THE CAUSE OF THE PROBLEM COULD BE PRODUCED BECAUSE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE ROOT CAUSE DESCRIPTION: NOT ABLE TO CONFIRM THE REPORTED ISSUE. POSSIBLE DAMAGE IN THE PLUNGER LIP PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A SYRINGE S2 5ML 22GA 1-1/4IN BD (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IN THE VENOUS BLOOD COLLECTION FOR THE PATIENT, AIR LEAKAGE OCCURRED, BLOOD COLLECTION WAS LESS, BLOOD COLLECTION WAS DIFFICULT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4947 SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1811192

    Patients

    Seq Age Sex Outcome Treatment
    1 Other