BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 8247801 · Received January 15, 2019

    Report

    Report Number
    1920898-2018-01007
    Event Type
    Malfunction
    Date Received
    January 15, 2019
    Date of Event
    December 21, 2018
    Report Date
    January 29, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A DEFORMED BARREL NEAR THE CANNULA. SAMPLE WAS FORWARDED TO MANUFACTURING (HOLDREGE) ON 18JAN2019 FOR FURTHER REVIEW. ON 22JAN2019 HOLDREGE RECEIVED (1) LOOSE 1CC, 12.7MM SYRINGE. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 AND HQA- 68 PRIOR TO BEING EVALUATED. UPON VISUAL EVALUATION, SIMILAR FINDINGS TO THOSE OF THE INITIAL EVALUATION DONE AT FRANKLIN LAKES WERE NOTED. THE BARREL HAD A SLIGHT BOW TO IT AND THE BARREL TIP HAD SOME DAMAGE ON IT. ROOT CAUSE DESCRIPTION: PROBABLE ROOT CAUSE FOR BOWED BARRELS INCLUDE THE DURATION THE BARRELS SIT IN A TOTE BEFORE USE, COULD CAUSE BOWED BARRELS. PROBABLE ROOT CAUSE FOR DAMAGED BARREL TIP, INFEED AT THE PRINTERS WHEN THE BARREL IS TRANSFERRED TO THE MANDRAL. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. RATIONALE: 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 BEFORE USE OF THE BD PLASTIPAK¿ SYRINGE THE NEEDLE HUB WAS DEFORMED LIKE MELTING.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). 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. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD PLASTIPAK¿ SYRINGE THE NEEDLE HUB WAS DEFORMED LIKE MELTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44359 BD PLASTIPAK¿ SYRINGE SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other