BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON

    MDR report key: 6966778 · Received October 20, 2017

    Report

    Report Number
    1058382-2017-00005
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Report Date
    October 20, 2017
    Manufacturer
    DR. JAPAN CO. LTD.
    Product Code
    BSP
    UDI-DI
    10612479201719
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER, (B)(4) WAS NOTIFIED OF THE COMPLAINT REPORTED WITH THE INFORMATION PROVIDED FROM THE CUSTOMER (ITEM# 3077V2 / LOT#70101Q) ON OCTOBER 10,2017. HOWEVER, ON NOVEMBER 6, 2017, THE CUSTOMER RETRACTED THE SUBMISSION OF THEIR INITIAL PRODUCT INFORMATION AND WAS NOT ABLE TO PROVIDE A LOT# ALONG WITH THE REPLACEMENT INFORMATION SUBMITTED (ITEM# 4631V2) FOR THE REPORTED DEVICE. WITHOUT THE LOT# OR A DEFECT DEVICE TO EXAMINE FOR PHYSICAL INVESTIGATION, THE MANUFACTURER COULD NOT CONDUCT A PROPER INVESTIGATION ON THE REPORTED INFORMATION PROVIDED. THE FOLLOWING BLOCKS WERE CORRECTED WITHIN THIS FOLLOW-UP MDR REPORT: THE CUSTOMER RETRACTED INITIAL INFORMATION (ITEM#3077V2 AND LOT#70101Q) SUBMITTED TO THE IMPORTER (B)(4). HOWEVER, THE REPLACEMENT ITEM# (4631V2) PROVIDED BY THE CUSTOMER REQUIRES A DIFFERENT 'COMMON DEVICE NAME'. THEREFORE THE INFORMATION IN THIS FIELD WILL BE CHANGE FROM EPIDURAL NEEDLE, PRODUCT CODE: BSP TO SPINAL NEEDLE, PRODUCT CODE: BSP. MANUFACTURER NAME, CITY, AND STATE INFORMATION HAS BEEN CHANGED FROM (B)(4) TO (B)(4). THIS CHANGE CAME AS AN UPDATE WITHIN THE FDA 'ESTABLISHMENT REGISTRATION & DEVICE LISTING' FOR (B)(4) CO., LTD. THE CURRENT ADDRESS LISTED WAS FOR THE MAIN OFFICE INSTEAD OF THE ACTUAL MANUFACTURER FACILITY ADDRESS. THEREFORE, THE CORRECT ADDRESS IS (B)(4) FOR THE MANUFACTURER NAME/ADDRESS. CATALOG#, THE CUSTOMER RETRACTED THE INITIAL REPORTING OF ITEM# 3077V2 TO REPORT ITEM# 4631V2 AS THE REPLACEMENT. THEREFORE, THE CORRECT ITEM# WILL BE LISTED AS 4631V2 IN THIS FIELD. LOT#, THE CUSTOMER RETRACTED THE INITIAL REPORTING OF THE LOT# 70101Q AND DID NOT PROVIDE REPLACEMENT LOT #, THEREFORE, THIS FIELD WILL REMAIN BLANK IN THIS FOLLOW-UP REPORT. EXPIRATION DATE, DUE TO THE CUSTOMER RETRACTING THE INITIAL REPORTING OF THE LOT# WITHOUT A REPLACEMENT, THE EXACT EXPIRATION DATE FOR THE REPORTED DEVICE CANNOT BE DETERMINED. THEREFORE, THIS FIELD WILL REMAIN BLANK IN THIS FOLLOW-UP REPORT. UNIQUE IDENTIFIER (UDI#), DUE TO THE CUSTOMER RETRACTING THE INITIAL ITEM# REPORTED, THE REPLACEMENT ITEM# DOES NOT CORRELATE WITH THE INITIAL UDI# RECORDED FOR THIS EVENT. THEREFORE, THE UDI# WILL BE UPDATED FROM (B)(4) AS REPORTED IN THIS MDRS INITIAL REPORT TO (B)(4) TO REFLECT THE REPLACEMENT ITEM#. AFTER FURTHER COMMUNICATION WITH THE CUSTOMER, IT WAS CONFIRMED THAT THE REPORTED DEVICE WAS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE SELECTION WILL BE CHANGED FROM 'NO INFORMATION' TO 'NO'. AFTER FURTHER COMMUNICATION WITH THE CUSTOMER, IT WAS CONFIRMED THAT THE END-USER'S INFORMATION WOULD NOT BE DISCLOSED FOR COMMUNICATION; THEREFORE, THE DISTRIBUTER'S INFORMATION FOR THE BEST PERSON TO CONTACT AS THE 'INITIAL REPORTER'. MANUFACTURER NAME/ADDRESS INFORMATION HAS BEEN CHANGED FROM (B)(4) TO (B)(4). THIS CHANGE CAME AS AN UPDATE WITHIN THE FDA 'ESTABLISHMENT REGISTRATION & DEVICE LISTING' FOR (B)(4) CO., LTD. THE CURRENT ADDRESS LISTED WAS FOR THE MAIN OFFICE INSTEAD OF THE ACTUAL MANUFACTURER FACILITY ADDRESS. THEREFORE, THE CORRECT ADDRESS IS (B)(4) FOR THE MANUFACTURER NAME/ADDRESS. DUE TO THE LACK OF INFORMATION AND NO DEFECT DEVICE AVAILABLE FOR EXAMINATION, THIS COMPLAINT FILE WAS CLOSED ON NOVEMBER 10, 2017 AND THEREFORE, WILL CONSIDER THIS MDR AS CLOSED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE NEEDLE FELL APART DURING A PROCEDURE. INJECTION WAS COMPLETE AND AS THE NEEDLE WAS BEING REMOVED, THE CLEAR TOP (HUB) CAME OFF AND LEFT THE NEEDLE IN THE PATIENT (WAS INSERTED APPROXIMATELY AN INCH). THE NEEDLE WAS ABLE TO BE REMOVED. NO INJURY OCCURRED TO PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE NEEDLE FELL APART DURING A PROCEDURE. INJECTION WAS COMPLETE AND AS THE NEEDLE WAS BEING REMOVED, THE CLEAR TOP (HUB) CAME OFF AND LEFT THE NEEDLE IN THE PATIENT (WAS INSERTED APPROXIMATELY AN INCH). THE NEEDLE WAS ABLE TO BE REMOVED. NO INJURY OCCURRED TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743744 MCKESSON SPINAL NEEDLE BSP DR. JAPAN CO. LTD. 70101Q 10612479201719

    Patients

    Seq Age Sex Outcome Treatment
    1