BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH NEEDLE

    MDR report key: 9035111 · Received September 13, 2019

    Report

    Report Number
    3002682307-2019-00503
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    August 29, 2019
    Report Date
    September 23, 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 SUMMARY: BD HAS BEEN PROVIDED WITH PHOTOS AND A SAMPLE FOR CATALOG 301940 LOT 1811161 TO INVESTIGATE FOR THIS RECORD. A LEAKAGE THROUGH THE PLUNGER ROD WAS OBSERVED. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. AFTER VISUAL EXAMINATION UNDER MAGNIFICATION, BD CONCLUDES THAT THE CAUSE OF THE PROBLEM WAS 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 AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. CONCLUSION: 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 · 0

    IT WAS REPORTED THAT THE BD SYRINGE¿ WITH NEEDLE LEAKED PAST THE STOPPER BEFORE USE WHEN THE NURSE PUMPED THE LIQUID. THIS OCCURRED ON 3 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "WHEN THE NURSE USED A SYRINGE TO PUMP THE LIQUID, HE FOUND THAT THE LIQUID LEAKED FROM THE PLUNGER AND COULD NOT BE USED FOR CLINICAL OPERATION."

    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 THE BD SYRINGE¿ WITH NEEDLE LEAKED PAST THE STOPPER BEFORE USE WHEN THE NURSE PUMPED THE LIQUID. THIS OCCURRED ON 3 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN THE NURSE USED A SYRINGE TO PUMP THE LIQUID, HE FOUND THAT THE LIQUID LEAKED FROM THE PLUNGER AND COULD NOT BE USED FOR CLINICAL OPERATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826489 BD SYRINGE WITH NEEDLE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1811161

    Patients

    Seq Age Sex Outcome Treatment
    1 Other