BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SP

    MDR report key: 13667327 · Received March 4, 2022

    Report

    Report Number
    3002682307-2022-00078
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    January 1, 2022
    Report Date
    April 13, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER FIRST NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306574 AND LOT NUMBERS 1187703, 1152011, AND 1257152. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. FOR LOT 1187703, THE PICTURES SHOWED SHELF CARTONS WITH HOLES, SHELF CARTONS DAMAGED BY THE GLUE OF THE CASE CARTON FLAPS, AND BROKEN PACKAGES. FOR LOT 1152001, THE PICTURES SHOWED SHELF CARTONS WITH HOLES, SHELF CARTONS WITH EXTRA OR MISPLACED LABELS AND OTHER PACKAGE DAMAGES. FOR LOT 1257152, THE PICTURES SHOWED SHELF CARTONS WITH HOLES, SHELF CARTONS WITH EXTRA LABELS, AND OTHER PACKAGE DAMAGES. DAMAGED SHELF CARTONS MAY OCCUR IN THE SECONDARY PACKAGING STATION IF A JAM HAPPENS. IF A JAM OCCURS, ALL MATERIAL MUST BE MOVED AWAY AND INSPECTED. IN THE TERTIARY PACKAGING STATION, SHELF CARTONS MAY ALSO BECOME DAMAGED IF A MALFUNCTION CAUSES THE SHELF CARTONS TO BE PLACED IN THE CASE CARTON INCORRECTLY. SHELF CARTONS THAT WERE NOT PROPERLY CLOSED COULD BE DUE TO DEFECTIVE MATERIAL, POOR CASTING, OR HIGH HUMIDITY, WHICH CAN LEAD TO PACKAGE BREAKAGE. HOLES IN THE SHELF CARTONS MAY OCCUR IF THE SECONDARY PACKAGING STATION IS NOT WELL ADJUSTED. THE STATION ARMS MAY APPLY TOO MUCH PRESSURE OR PICK UP THE SYRINGES INCORRECTLY SO THAT THE SYRINGE BREAKS THE SHELF CARTON UPON PLACEMENT. THIS TYPE OF ISSUE USUALLY AFFECTS THE BOTTOM OF THE SHELF CARTON. THE EXTRA LABELS MAY OCCUR IF A JAM IN THE BELT OF THE SHELF CARTON LABEL PRINTER OCCURS. LARGE LABELS MAY RESULT DUE TO DEFECTIVE LABEL ROLLS THAT ARE NOT CORRECTLY CUT BY THE SUPPLIER. SHELF CARTON INTEGRITY AND LABELING IS INSPECTED HOURLY AND AT LOT CHANGE BASED ON OUR PROCEDURES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ SP WAS MISSING LABEL INFORMATION. THIS EVENT OCCURRED 2 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DAMAGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ SP WAS MISSING LABEL INFORMATION. THIS EVENT OCCURRED 2 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2568667 BD POSIFLUSH¿ SP SALINE VASCULAR ACCESS FLUSH NGT BECTON DICKINSON, S.A. 1257152

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown