BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE FOR SPINAL ANESTHESIA SPINAL

    MDR report key: 7889127 · Received September 19, 2018

    Report

    Report Number
    9610048-2018-00135
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Date of Event
    August 28, 2018
    Report Date
    October 2, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    BSP
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: OUR QUALITY ENGINEER WAS ABLE TO VERIFY THE REPORTED COMPLAINT PER THE PROVIDED PICTURES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR CATALOG #408381 LOT 7151725 MANUFACTURED FROM 07-JUN-17 TO 10-JUN-17 USED IN CLAIMED LOT 7151725. IT WAS REVIEWED THE TESTS PERFORMED IN THE PACKAGING/ LABELING PROCESS TO VERIFY THE IDENTIFICATION OF THE SHELF BOXES AND DISPENSER BOXES AND NO RECORDS THAT COULD LEAD TO THIS COMPLAINT WERE EVIDENCED. IN ADDITION, IT WAS REVIEWED THE QUANTITY OF PRINTED LABELS WERE MADE TO DISPENSER BOXES. ACCORDING TO THE RECORDS, THE TOTAL OF UNITS OF THIS LOT WAS OF (B)(4) UNITS WITH DISPENSER BOXES CONTAINING 25 UNITS. THIS WAY, IT WOULD BE NECESSARY EXACTLY 10,303 PRINTED LABELS TO BE USED IN ALL LOT. DURING THIS REVIEW IT EVIDENCED THAT WERE PRINTED 10,319 UNITS OF PRINTED LABELS, THAT IT WOULD BE MORE THAN ENOUGH TO BE USED IN THE LOT. QN/ NCMR REVIEW: THERE ARE NO QUALITY NOTIFICATION (QN) OR NON-CONFORMITY REPORT RECORDS OF THIS ISSUE, FOR THE LOT INVOLVED IN THIS COMPLAINT. BASED ON THE INVESTIGATIONS, IT IS BELIEVED THAT THIS ISSUE HAS BEEN CAUSED BY A HUMAN FAILURE DURING THE MANUAL LABELING OF THE DISPENSER BOXES BY THE OPERATORS RESPONSIBLE FOR THIS OPERATION. IT SHOULD BE NOTED THAT ALL THE INFORMATION CONTAINED ON THE MISSING LABEL OF THE CLAIMED DISPENSER BOXES, SUCH AS: CODE, LOT, PRODUCT DESCRIPTION AND EXPIRATION DATE, ARE PRESENT IN THE UNIT PACKAGES INSIDE THE DISPENSER BOXES. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. ADDITIONAL EMPLOYEE TRAINING WAS CARRIED OUT FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD¿ NEEDLE FOR SPINAL ANESTHESIA SPINAL THERE WAS AN ISSUE WITH LABELING ERROR. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE#: (B)(6). 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 WITH THE USE OF THE BD¿ NEEDLE FOR SPINAL ANESTHESIA SPINAL THERE WAS AN ISSUE WITH LABELING ERROR. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729335 BD¿ NEEDLE FOR SPINAL ANESTHESIA SPINAL SPINAL NEEDLE BSP BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7151725

    Patients

    Seq Age Sex Outcome Treatment
    1 Other