BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE¿ PLUS X100L PNG CLEAR

    MDR report key: 7774348 · Received August 10, 2018

    Report

    Report Number
    3001741852-2018-00013
    Event Type
    Malfunction
    Date Received
    August 10, 2018
    Date of Event
    July 17, 2018
    Report Date
    September 20, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    MEG
    PMA / PMN Number
    K123743
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES. DURING SAMPLE ANALYSIS THE DEVICES WERE ACTIVATED AND IT FUNCTIONED NORMALLY. HOWEVER BD SWINDON CONFIRMS THAT THE STOP TABS ARE BENT FOR 17 DEVICES. THE MANUFACTURING LINE FOR THIS PRODUCT IS NO LONGER IN BD-SWINDON. IT HAS BEEN TRANSFERRED TO ANOTHER BD SITE. AS THIS LINE IS NOT OPERATIONAL CURRENTLY AND STILL UNDER VALIDATION, A SIMILAR LINE WAS REVIEWED. IT HAS BEEN OBSERVED THAT THIS ISSUE COULD NOT HAVE HAPPENED AT THE SUPPLIERS OR BEFORE ASSEMBLY AS THERE IS A CAMERA WHERE THE STOP TAB ON THE BODY COMPONENT IS CHECKED BEFORE THE ASSEMBLY, AND THIS IS ABLE TO DETECT THIS KIND OF FAILURE. IT IS LIKELY THAT THE ISSUE HAS OCCURRED DURING OR AFTER ASSEMBLY OF ALL THE COMPONENTS. HOWEVER BD-SWINDON HAS PRODUCED OVER 200 BATCHES AND THIS IS THE FIRST REPORTED COMPLAINT OF THIS NATURE. THE OTHER BD SITE ALSO HAVE NEVER HAD REPORTED INCIDENTS OF THIS NATURE ON THE SIMILAR MANUFACTURING LINE. BATCH HISTORY RECORD REVIEW DID NOT INDICATE OF ANY ISSUES RELATED TO THE PROBLEM STATEMENT. THERE IS POTENTIAL THAT THE DEVICES COULD HAVE BEEN DAMAGED DURING CUSTOMER ASSEMBLY AT THE LOADING PHASE. HOWEVER THIS IS BEYOND THE SCOPE OF BD SWINDON. THE CUSTOMER HAS NOT COMPLAINED OF FINDING UNUSED SAMPLES WITH BENT STOP TABS IN TRAYS PRIOR TO BEING LOADED ONTO THE ASSEMBLY LINE. THE TOTAL NUMBER OF PARTS AFFECTED ARE NOT DETERMINED BY THE CUSTOMER FOR THE AFFECTED BATCH 7250250 THEREFORE THE DEFECT RATE WILL BE CALCULATED ON THE NUMBER OF SAMPLES RECEIVED IN A FULL BATCH OF FINAL PRODUCT. AS REQUESTED BY THE CUSTOMER, THE BATCH RECORDS FOR 7081433 HAVE BEEN CHECKED AND NO ISSUES HAVE BEEN REPORTED IN RELATION TO THE PROBLEM STATEMENT. BASED ON THE INVESTIGATION CONCLUSION, BDM-PS WAS ABLE TO CONFIRM THE DETECTION BUT COULD NOT CHARACTERIZE THE CONDITION REPORTED BY THE CUSTOMER ENTIRELY TO A BD-SWINDON PROCESS. THE REPORTED CONDITION, HAS BEEN CONFIRMED TO BE WITHIN THE SPECIFIED ACCEPTABLE QUALITY LEVEL (AQL¿S) DEFINED IN THE APPLICABLE SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE ARE BD ULTRASAFE PLUS X100L PNG CLEARS WITH PROTRUDING PIECES OF DEVICE MATERIAL OR FLASH GATES THAT ARE PREVENTING THE DEVICE FROM GOING THROUGH THEIR MACHINES. THESE FLASH GATES COULD ALSO CAUSE POTENTIAL HARM OR INJURY. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 47451101, MEDICAL DEVICE EXPIRATION DATE: 2022-08-31, DEVICE MANUFACTURE DATE: 2017-09-07. MEDICAL DEVICE LOT #: 7081433, MEDICAL DEVICE EXPIRATION DATE: 2021-02-28, DEVICE MANUFACTURE DATE: 2017-03-22. (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 THAT THERE ARE BD ULTRASAFE¿ PLUS X100L PNG CLEARS WITH PROTRUDING PIECES OF DEVICE MATERIAL OR FLASH GATES THAT ARE PREVENTING THE DEVICE FROM GOING THROUGH THEIR MACHINES. THESE FLASH GATES COULD ALSO CAUSE POTENTIAL HARM OR INJURY. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612925 BD ULTRASAFE¿ PLUS X100L PNG CLEAR PISTON SYRINGE MEG BECTON DICKINSON SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other