BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 0.5ML 31GX5/16 (8MM)

    MDR report key: 6859614 · Received September 12, 2017

    Report

    Report Number
    1920898-2017-00172
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    August 21, 2017
    Report Date
    November 11, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. SAMPLES RECEIVED IN COMPLAINTS LAB AND PLACED IN DC FIFO INVESTIGATION BUCKET DATED (B)(6) 2017. (B)(6), (B)(6) 2017. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1/2CC, 8MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 7121995. CUSTOMER STATES THAT THE UNIT MARKING IS SMEARED. UPON EVALUATION BY QE AH, IT WAS NOTED THAT THE SAMPLE RECEIVED EXHIBITED A SMEARING OF THE INK JUST PAST THE 35U (35 UNITS) MARKING ALONG THE BARREL. THE SMEARED INK EXTENDED ALONG THE REMAINDER OF THE REMAINDER OF THE PRINTING AREA ALONG THE BARREL, 35U TO BEYOND 50U (35 UNITS TO 50 UNITS), INCLUDING THE SYRINGE SIZE PRINTING. A REVIEW OF THE DEVICE HISTORY RECORDS NOTED ADDITIONAL DEFECTS FOUND DURING PRODUCTION OF THIS BATCH, AS THEY RELATE TO THIS COMPLAINT CAUSE. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE DEVICE HISTORY RECORD REVIEW ¿ A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7121995. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED SMEARED INK ON THE SURFACE OF THE BARREL. HOLDREGE RECEIVED ONE (1) 0.5ML, 8MM, AND 31G SYRINGE IN AN OPENED POLYBAG FROM BATCH # 7121995. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. 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. POSSIBLE ROOT CAUSE IS ATTRIBUTED TO PAD SWELLING ON THE MANDRIL DURING THE PRINTING PROCESS. AS THE PADS ARE USED, THEY GRADUALLY SWELL AND CAN CAUSE THIS TYPE OF "SMEAR" OR "SMUDGE AFFECT. A PROBLEM SOLVING TEAM HAS BEEN TASKED WITH IMPROVING PRINT QUALITY ON ALL PRODUCTION LINES WITHIN THE PLANT. THE TEAM IS SYSTEMATICALLY ASSESSING AND ADDRESSING EACH PRINTER INDIVIDUALLY FOR IMPROVEMENTS. CAPA (B)(4) WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS PRINT RELATED DEFECTS AND THEIR ASSOCIATED ROOT CAUSE(S).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 0.5ML 31GX5/16 (8MM) WITH THE UNIT MARKINGS SMEARED, AND THE SCALE MARKINGS ONLY WENT UP TO 35 UNITS. THIS WAS IDENTIFIED BEFORE USE, WITH NO SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640494 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 0.5ML 31GX5/16 (8MM) INSULIN SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 7121995

    Patients

    Seq Age Sex Outcome Treatment
    1 Other