BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE S2 5ML

    MDR report key: 8885413 · Received August 12, 2019

    Report

    Report Number
    3002682307-2019-00443
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    June 24, 2019
    Report Date
    September 9, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    JKA
    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 WAS NOT PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 301942 LOT 1803151 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. BD HAS DETERMINED THAT NO RE-WORK WAS DONE WITH PRODUCT OF THIS BATCH. THE MOST PROBABLE ROOT CAUSE COULD BE RELATED TO THE STORAGE OR TRANSPORT OF THE PRODUCT AFTER PRODUCTION. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: D.1. MEDICAL DEVICE BRAND NAME: BD¿ SYRINGE S2 5ML D.2. MEDICAL DEVICE TYPE: N/A. D.2. COMMON DEVICE NAME: SYRINGE. D.2. MEDICAL DEVICE CATALOG #: 301942. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.5. PMA/510(K)#: N/A. H.4. DEVICE MANUFACTURE DATE: 2018-03-08.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SYRINGE S2 5ML PACKAGE WAS DAMAGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT THE PACKAGE DAMAGED BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SYRINGE S2 5ML PACKAGE WAS DAMAGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT THE PACKAGE DAMAGED BEFORE USE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES PACKAGE WAS DAMAGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT THE PACKAGE DAMAGED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679821 BD¿ SYRINGE S2 5ML SYRINGE JKA BECTON DICKINSON, S.A. 1803151

    Patients

    Seq Age Sex Outcome Treatment
    1 Other