BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31GA 6MM

    MDR report key: 10071522 · Received May 19, 2020

    Report

    Report Number
    1920898-2020-00546
    Event Type
    Malfunction
    Date Received
    May 19, 2020
    Date of Event
    May 4, 2020
    Report Date
    June 17, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249121
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (73) 31GX6MM, 1ML BD INSULIN SYRINGES FROM LOT 9140733 (60 IN SEALED POLYBAGS, 13 LOOSE). CONSUMER REPORTED 10 SYRINGES WITH ANGLED BARRELS ON THEM. ALL 13 LOOSE SYRINGES WERE EXAMINED, AND IT WAS OBSERVED THAT 4 SYRINGES EXHIBITED BOWED BARRELS. 30 OUT OF THE 60 SAMPLES RETURNED IN SEALED POLYBAGS WERE SELECTED AND EXAMINED, AND NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9140733. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. PROCESS SUMMARY: THE AUTOMATIC SYRINGE ASSEMBLY MACHINE FEEDS 1ML SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, AND CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL-CLEANING DIAL, LUBRICATION DIAL, ONE PLUNGER/STOPPER ASSEMBLY DIAL AND ONE SYRINGE ASSEMBLY DIAL AND VARIOUS INSPECTION AND TRANSFER DIALS. THERE WERE NO QUALITY NOTIFICATIONS OR MAINTENANCE DISPATCHES THAT PERTAINED TO THIS DEFECT DURING THE PRODUCTION OF THIS BATCH. A ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-06-30. D.4. MEDICAL DEVICE LOT #: 9140733. D.10. DEVICE AVAILABLE FOR EVAL? YES. D.10. RETURNED TO MANUFACTURER ON: 2020-05-13. H.3. DEVICE RETURNED TO MANUFACTURER: YES. H.4. DEVICE MANUFACTURE DATE: 2019-05-20.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BOWED BARREL WAS FOUND DURING USE WITH A SYRINGE 1.0ML 31GA 6MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PHARMACIST REPORTED HER PATIENT RETURNED 2 PACKETS OF 10 SYRINGES WITH ANGLED BARRELS ON THEM." 2 OCCURRENCES WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BOWED BARREL WAS FOUND DURING USE WITH A SYRINGE 1.0ML 31GA 6MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PHARMACIST REPORTED HER PATIENT RETURNED 2 PACKETS OF 10 SYRINGES WITH ANGLED BARRELS ON THEM." 2 OCCURRENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 A BOWED BARREL WAS FOUND DURING USE WITH A SYRINGE 1.0ML 31GA 6MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PHARMACIST REPORTED HER PATIENT RETURNED 2 PACKETS OF 10 SYRINGES WITH ANGLED BARRELS ON THEM." 2 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536916 SYRINGE 1.0ML 31GA 6MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324912 9140733 00382903249121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other