BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7648192 · Received June 28, 2018

    Report

    Report Number
    1920898-2018-00461
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    June 8, 2018
    Report Date
    September 5, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138345
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO EVALUATIONS WERE CARRIED OUT. FRANKLIN LAKES INVESTIGATION SUMMARY: CUSTOMER RETURNED (4) 1CC, 6MM, 31G RELION SYRINGES IN AN OPEN POLY BAG FROM LOT#: 8022941. CUSTOMER STATES THAT THE PLUNGER ROD IS LOOSE AND FALLS OUT OF THE SYRINGE. ALL RETURNED SYRINGES WERE EXAMINED AND ALL EXHIBITED A MISSING STOPPER WHICH COULD CAUSE THE PLUNGER ROD TO FALL OUT OF THE BARREL. NO DAMAGE TO THE PLUNGERS WAS OBSERVED. SAMPLES WERE FORWARDED TO MANUFACTURING (HOLDREGE) ON 13JUL2018 FOR FURTHER REVIEW. HOLDREGE INVESTIGATION SUMMARY: ON 18JUL2018, HOLDREGE RECEIVED FOUR (4) 1ML, 6MM, 31G RELION SYRINGES IN AN OPENED POLYBAG FROM BATCH#: 8022941. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO EVALUATION. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. ADDITIONALLY, ALL SAMPLES WERE DISASSEMBLED AND THE PLUNGER ROD VISUALLY INSPECTED. NO ABNORMAL FINDINGS WERE NOTED FROM THIS EVALUATION AT THIS TIME. POSSIBLE ROOT CAUSE(S) INCLUDE, BUT ARE NOT LIMITED TO: A JAM ON THE METRO DURING PLUNGER ROD/STOPPER ASSEMBLY, A SUPPLIER RELATED MOLDING OR CUT DEFECT OF THE STOPPER PRIOR TO ASSEMBLY AND/OR A PART IN THE DIAL PATHWAY AT THE POINT OF ASSEMBLY THAT INHIBITED COMPLETION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#: 8022941. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR PLUNGER ROD LOOSE ON LOT#: 8022941. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (MISSING STOPPER). 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 THE PLUNGER ROD OF A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE IS LOOSE AND FALLS OUT. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: N/A. 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.

    Additional Manufacturer Narrative · 1

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER ROD OF A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE IS LOOSE AND FALLS OUT. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER ROD OF A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE IS LOOSE AND FALLS OUT. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491271 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 8022941 00681131138345

    Patients

    Seq Age Sex Outcome Treatment
    1 Other