BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION¿ INSULIN SYRINGE

    MDR report key: 7401007 · Received April 5, 2018

    Report

    Report Number
    1920898-2018-00186
    Event Type
    Malfunction
    Date Received
    April 5, 2018
    Date of Event
    March 1, 2018
    Report Date
    May 21, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311762
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO INVESTIGATIONS WERE CARRIED OUT. FIRST INVESTIGATION SUMMARY: CUSTOMER RETURNED (3) 1/2CC, 8MM, 31G RELION SYRINGES IN AN OPEN POLY BAG FROM LOT # 6242675. CUSTOMER STATES THAT THE INK SEEMS TO BE SMUDGED. ALL RETURNED SYRINGES WERE EXAMINED AND ALL EXHIBITED INK SMEARS ON THE SURFACE OF THE BARREL. SAMPLES WERE FORWARDED TO MANUFACTURING (HOLDREGE) ON 27APR2018 FOR FURTHER REVIEW. SECOND INVESTIGATION SUMMARY: ON (B)(6)2018, HOLDREGE RECEIVED THREE (3) 0.5ML, 8MM, 31G RELION SYRINGES IN AN OPENED POLYBAG FROM BATCH# 6242675. 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. PROBABLE ROOT CAUSE LIKELY TO BE A SWOLLEN PAD ON THE PRINTER DURING MANUFACTURING. WHEN THIS OCCURS, ADDITIONAL INK/SMEARS MAY OCCUR AS THE SWOLLEN PAD CAN TOUCH THE BARREL SURFACE AT MORE POINTS THAN JUST THE SCALE PRINT AREAS. THE RESULTING DEFECT CAN MAKE IT'S WAY INTO FINAL PACKAGING AND ON TO THE CONSUMER WITHOUT BEING NOTED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6242675. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200660922] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR SCALE PRINTING SMUDGED ON LOT # 6242675. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. 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 162566 WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS PRINT RELATED DEFECTS AND THEIR ASSOCIATED ROOT CAUSE(S). BATCH# 6242675 WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF CORRECTIVE/PREVENTIVE ACTIONS ASSOCIATED WITH THIS CAPA. 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. 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 SEVERAL RELION¿ INSULIN SYRINGE(S) HAD SMUDGED AND ILLEGIBLE SCALE MARKINGS. THE PRODUCT WAS NOT USED AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244276 RELION¿ INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 6242675 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1 Other