BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ INSULIN SYRINGE NEEDLE

    MDR report key: 7467146 · Received April 26, 2018

    Report

    Report Number
    1920898-2018-00274
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    April 4, 2018
    Report Date
    May 23, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    K955235
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWO INVESTIGATIONS WERE CARRIED OUT. FIRST INVESTIGATION SUMMARY: CUSTOMER RETURNED (3) LOOSE 1/2CC SYRINGES WITHOUT ANY PACKAGING FILLED WITH APPROXIMATELY 5 UNITS OF A CLEAR LIQUID IN THE BARREL. CUSTOMER STATES THAT THERE IS A SIGNIFICANT CLOUDINESS WHEN FILLING. ALL RETURNED SYRINGES WERE EXAMINED VISUALLY AND UNDER THE MICROSCOPE AND ALL EXHIBITED DARK SPECKS OF MATERIAL ON THE OUTER SURFACE OF THE BARREL. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE BARREL AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SUGGESTS THAT THIS MATERIAL HAS COMPONENTS SIMILAR TO THOSE OF SCALE PRINT INK. SAMPLES WILL BE FORWARDED TO MANUFACTURING (HOLDREGE) ON 04MAY2018 FOR FURTHER REVIEW. SECOND INVESTIGATION SUMMARY: ON 09MAY2018, HOLDREGE RECEIVED THREE (3) LOOSE 0.5ML SYRINGES FILLED WITH APPROXIMATELY 5U (5 UNITS) OF CLEAR LIQUID, DOCUMENTED IN A NOTE AS WATER AND/OR AVASTIN. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. THE REPORTED COMPLAINT CAUSE, AS NOTED DURING EVALUATION IN BD FRANKLIN LAKES, REPRESENTS A COSMETIC DEFECT ONLY AND WOULD NOT BE DETERMINED TO BE REJECTABLE IF NOTED DURING MANUFACTURING OF THIS BATCH. VARIATION IN PRINT, BASED ON RELATIVE PAD SATURATION/SWELLING, CAN OCCUR AND IS AN EXPECTED PART OF THE MANUFACTURING PROCESS. ALTHOUGH CAPA 162566 WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS PRINT RELATED DEFECTS AND THEIR ASSOCIATED ROOT CAUSE(S), THESE COMPLAINT SAMPLES DO NOT REFLECT A DEFECT AT THIS TIME. A DHR COULD NOT BE PERFORMED AS THE BATCH AND CATALOG NUMBER DO NOT MATCH. SEVERITY: S_3__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR FOREIGN MATTER ON LOT # 7086624. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (SMEARED INK). 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.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A 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 WHEN FILLING A BD MICRO-FINE¿ INSULIN SYRINGE NEEDLE WITH DRUG SOLUTION FOR EYE TREATMENT, A PHARMACIST COMPLAINED THERE WAS "SIGNIFICANT CLOUDINESS" FOUND. THERE WAS NO REPORT OF ADDITIONAL TREATMENT OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308822 BD MICRO-FINE¿ INSULIN SYRINGE NEEDLE INSULIN SYRINGE FMI BD MEDICAL - DIABETES CARE 7086624

    Patients

    Seq Age Sex Outcome Treatment
    1 Other