BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN SYRINGES ULTRA-FINE NEEDLE

    MDR report key: 7636562 · Received June 25, 2018

    Report

    Report Number
    1920898-2018-00436
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    June 4, 2018
    Report Date
    July 30, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO INVESTIGATIONS WERE CARRIED OUT. FRANKLIN LAKES INVESTIGATION SUMMARY: CUSTOMER RETURNED (20) 1CC, 12.7MM, 29G SYRINGES IN SEALED POLY BAGS FROM LOT # 7100916. CUSTOMER STATES THAT THERE WAS A NEEDLE STICK INJURY DUE TO A NEEDLE WITHOUT A CAP IN AN UNOPENED BAG. BOTH RETURNED POLY BAGS WERE EXAMINED AND 7 OUT OF 20 SAMPLES EXHIBITED THE SHIELD LOOSE IN THE BAG WITH THE CANNULA EXPOSED. SINCE THE CANNULA WAS EXPOSED, A NEEDLE STICK COULD OCCUR. SAMPLES WERE FORWARDED TO MANUFACTURING (HOLDREGE) ON 13JUL2018 FOR FURTHER REVIEW. HOLDREGE INVESTIGATION SUMMARY: ON 18JUL2018, HOLDREGE RECEIVED TWENTY (20) 1ML, 12.7MM, 29G SYRINGES IN SEALED POLYBAGS FROM 7100916, ALL HOUSED WITHIN A YELLOW BD HOME SHARPS CONTAINER. ADDITIONALLY, A PHOTOGRAPH WAS PROVIDED BY THE COMPLAINANT WITH THIS RECORD. ALL SAMPLES WERE DECONTAMINATED PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. FROM THE LIMITED VIEWING CAPABILITIES WITHIN THE SHARPS CONTAINER, NO OBVIOUS DAMAGE TO THE SHIELDS OR POLYBAG WERE NOTED, SUGGESTING THAT THESE POLYBAGS WERE NOT NECESSARILY A PART OF A JAW JAM EVENT ON THE FFS (FORM FILL & SEAL) EQUIPMENT. IT IS POSSIBLE THAT DURING THE PACKAGING OF THE POLYBAGS INTO THE CARTON, THAT THE SHUBERT EQUIPMENT COULD CAUSE SUCH AN EVENT TO HAPPEN. FURTHER ROOT CAUSE(S) FOR DEFECTS NOTED WITHIN THE RETURNED SAMPLES ARE UNABLE TO BE EVALUATED AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7100916. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200695005, 200695004, 200695049] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE STICK INJURY AND THE 1ST RELATED COMPLAINT FOR NEEDLE SHIELD SEPARATED ON LOT # 7100916. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. BASED ON THE ABOVE, NO CAPA IS REQUIRED AT THIS TIME. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE STICK INJURY OCCURED WHEN THE CAP WAS OFF OF THE BD INSULIN SYRINGES ULTRA-FINE¿ NEEDLE IN THE UNOPENED PACKAGE CAUSING STERILITY BREACH. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER EMAIL: (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 A NEEDLE STICK INJURY OCCURED WHEN THE CAP WAS OFF OF THE BD INSULIN SYRINGES ULTRA-FINE¿ NEEDLE IN THE UNOPENED PACKAGE CAUSING STERILITY BREACH. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475345 INSULIN SYRINGES ULTRA-FINE NEEDLE INSULIN SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 7100916

    Patients

    Seq Age Sex Outcome Treatment
    1 Other