BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ STERILE INSULIN SYRINGE

    MDR report key: 7182522 · Received January 11, 2018

    Report

    Report Number
    1920898-2017-00452
    Event Type
    Malfunction
    Date Received
    January 11, 2018
    Date of Event
    October 24, 2017
    Report Date
    March 12, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED ONE 1CC, 12.7MM, 29G U40 SYRINGE IN AN OPEN BLISTER PACK FROM LOT # 6060630. CUSTOMER STATES THERE IS FOREIGN MATTER ON THE NEEDLE TIP BEFORE USE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A CLEAR PIECE OF MATERIAL LOOSELY HELD ON THE CANNULA SHAFT. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SUGGESTS THAT THIS MATERIAL HAS COMPONENTS SIMILAR TO THOSE OF POLYETHYLENE ALONG WITH SILICONE FROM THE CANNULA. UPON EVALUATION BY QE AH, SIMILAR FINDINGS AS THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD (B)(4) WERE NOTED. PROBABLE ROOT CAUSE IS LIKELY THAT THE "ANGEL HAIR" WAS CREATED WHEN MOVING COMPONENTS ACROSS THE PRODUCTION FLOOR. WHEN THIS TYPE OF TRANSPORT OCCURS WITHIN THE MANUFACTURING PLANT, FILAMENTS SUCH AS SEEN WITHIN THE SAMPLE RECEIVED, MAY FIND THEIR WAY INTO ANY PORTION OF THE SYRINGE AND THEN ON TO THE CONSUMER. CONTINUOUS IMPROVEMENT PROJECTS WITHIN THE PLANT ARE CURRENTLY EVALUATING UPGRADES TO THE TRANSPORT SYSTEM THAT MIGHT REDUCE AND/OR ELIMINATE "ANGEL HAIR" FROM BEING PRODUCED. AS PER MANUFACTURING, A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 6060630. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO NOTIFICATIONS (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS INDICATED FAILURE COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE, NO CAPA IS REQUIRED AT THIS TIME. INVESTIGATION CONCLUSION: THIS FM LIKELY REPRESENTS WHAT WE CALL ANGEL HAIR. THIS IS CREATED WHEN WE MOVE COMPONENTS FROM ONE LINE TO ANOTHER VIA THE TUBE PEA SHOOTERS. THIS IS A PRESSURIZED TUBING TRANSPORT SYSTEM MADE OF POLYETHYLENE PLASTIC; AS THE COMPONENTS MOVE THROUGH THE PEA SHOOTERS, OCCASIONALLY SMALL FRAGMENTS OF THE PLASTIC TUBE ARE STRIPPED OFF AND FORM THIS ANGEL HAIR. IN THIS CASE, IT MOST LIKELY FOUND ITS WAY INTO THE SHIELD AND ULTIMATELY ONTO THE CANNULA. THERE ARE VARIOUS EFFORTS WITHIN THE PLANT TO TRY AND HELP REDUCE AND HOPEFULLY ELIMINATE THIS, HOWEVER, IT IS AN INHERENT PORTION OF THE PROCESS AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE NEEDLE OF A BD" STERILE INSULIN SYRINGE, BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27924 BD¿ STERILE INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 6060630

    Patients

    Seq Age Sex Outcome Treatment
    1 Other