BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7455271 · Received April 24, 2018

    Report

    Report Number
    1920898-2018-00262
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    April 4, 2018
    Report Date
    May 14, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: TWO INVESTIGATIONS WERE CARRIED OUT. FIRST INVESTIGATION SUMMARY: CUSTOMER RETURNED (3) 3/10CC, 8MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 7100846. CUSTOMER STATES THAT THE PLUNGER CAP WAS OFF OF THE SYRINGE IN THE BAG. ALL RETURNED SYRINGES WERE RETURNED WITHOUT THE PLUNGER CAP. NO DAMAGE WAS OBSERVED ON THE RETURNED SYRINGES. SAMPLES WERE FORWARDED TO MANUFACTURING (HOLDREGE) ON 27APR2018 FOR FURTHER REVIEW. SECOND INVESTIGATION SUMMARY: ON 01MAY2018, HOLDREGE RECEIVED THREE (3) 0.3ML, 8MM, 31G SYRINGES IN AN OPENED POLYBAG FROM BATCH # 7100846. 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. NO CAPS FROM ANY OF THE SAMPLES WERE RETURNED, HOWEVER, THEREFORE ASSESSMENT TO DAMAGE TO THE CAPS THEMSELVES IS UNABLE TO BE DETERMINED. ADDITIONALLY, ALL SAMPLES WERE RECEIVED WITH THE PLUNGER ROD COMPLETELY DEPRESSED WITH THE SYRINGE BARREL, WHICH IS UNUSUAL FOR UNUSED DEVICES. DURING PRODUCTION, THE PLUNGER ROD IS ASSEMBLED TO STOP BETWEEN THE 1-2U (1-2 UNITS) MARKINGS ON THE BARREL. A PROBABLE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7100846 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE (0) ZERO NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. SEVERITY: S1; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR PLUNGER CAP SEPARATES IN POLYBAG ON LOT # 7100846. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (MISSING PLUNGER CAP). 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.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THE PLUNGER CAP OF THE BD VACUTAINER® GLASS CPT MOLECULAR DIAGNOSTICS TUBE WAS OFF OF THE SYRINGE IN THE BAG PRIOR TO USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299778 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7100846

    Patients

    Seq Age Sex Outcome Treatment
    1 Other