BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE IV INSULIN SYRINGE

    MDR report key: 11121460 · Received January 5, 2021

    Report

    Report Number
    1920898-2020-01798
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    December 9, 2020
    Report Date
    March 5, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903294245
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-02-22. INVESTIGATION SUMMARY: CUSTOMER RETURNED (3) 1CC, 12.7MM, 28G SYRINGES IN BLISTER PACKS FROM LOT # 9119537, 9322637, 0160417, 0099954, 9294983, 9231122, 9196270, 9189788, 9168926, 9140521, 8351757, AND 8302667. CUSTOMER STATES THAT THE PACKAGING WAS NOT SEALED ON ONE SIDE. ALL RETURNED SYRINGES WERE EXAMINED AND ALL BLISTER PACKS WERE OBSERVED TO BE OPEN. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9119537, 9322637, 0160417, 0099954, 9294983, 9287332, 9231122, 9196270, 9189788, 9168926, 9140521, 8351757, AND 8302667. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SEVERAL BD MICRO-FINE¿ IV INSULIN SYRINGES HAD ISSUES WITH PARTIAL UNSEALED PACKAGING UNITS. THERE WERE 3 FROM LOT 9119537, 14 FROM 9140521, 18 FROM 9168926, 30 FROM 9189788, 25 FROM 9196270, 5 FROM 9231122, 1 FROM 9287332, 38 FROM 9294983, 15 FROM 0099954, 256 FROM 0160417, 23 FROM 8302667, 36 FROM 8351757, AND 3 FROM 9322637. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ITEM 329424, A TOTAL OF 467 UNITS ACROSS 13 LOT NUMBERS WERE FOUND TO BE PARTLY UNSEALED"

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9119537. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2019-04-29. MEDICAL DEVICE LOT #: 9140521. MEDICAL DEVICE EXPIRATION DATE: 2024-08-31. DEVICE MANUFACTURE DATE: 2019-05-20. MEDICAL DEVICE LOT #: 9168926. MEDICAL DEVICE EXPIRATION DATE: 2024-09-30. DEVICE MANUFACTURE DATE: 2019-06-17. MEDICAL DEVICE LOT #: 9189788. MEDICAL DEVICE EXPIRATION DATE: 2024-09-30. DEVICE MANUFACTURE DATE: 2019-07-08. MEDICAL DEVICE LOT #: 9196270. MEDICAL DEVICE EXPIRATION DATE: 2024-10-31. DEVICE MANUFACTURE DATE: 2019-07-15. MEDICAL DEVICE LOT #: 9231122. MEDICAL DEVICE EXPIRATION DATE: 2024-11-30. DEVICE MANUFACTURE DATE: 2019-08-19. MEDICAL DEVICE LOT #: 9287332. MEDICAL DEVICE EXPIRATION DATE: 2024-12-31. DEVICE MANUFACTURE DATE: 2019-10-14. MEDICAL DEVICE LOT #: 9294983. MEDICAL DEVICE EXPIRATION DATE: 2024-12-31. DEVICE MANUFACTURE DATE: 2019-10-21. MEDICAL DEVICE LOT #: 0099954. MEDICAL DEVICE EXPIRATION DATE: 2025-06-30. DEVICE MANUFACTURE DATE: 2020-04-08. MEDICAL DEVICE LOT #: 0160417. MEDICAL DEVICE EXPIRATION DATE: 2025-08-31. DEVICE MANUFACTURE DATE: 2020-06-08. MEDICAL DEVICE LOT #: 8302667. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. DEVICE MANUFACTURE DATE: 2018-10-29. MEDICAL DEVICE LOT #: 8351757. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2018-12-17. MEDICAL DEVICE LOT #: 9322637. MEDICAL DEVICE EXPIRATION DATE: 2025-02-28. DEVICE MANUFACTURE DATE: 2019-11-18. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL BD MICRO-FINE¿ IV INSULIN SYRINGES HAD ISSUES WITH PARTIAL UNSEALED PACKAGING UNITS. THERE WERE 3 FROM LOT 9119537, 14 FROM 9140521, 18 FROM 9168926, 30 FROM 9189788, 25 FROM 9196270, 5 FROM 9231122, 1 FROM 9287332, 38 FROM 9294983, 15 FROM 0099954, 256 FROM 0160417, 23 FROM 8302667, 36 FROM 8351757, AND 3 FROM 9322637. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ITEM 329424, A TOTAL OF 467 UNITS ACROSS 13 LOT NUMBERS WERE FOUND TO BE PARTLY UNSEALED"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17854 BD MICRO-FINE IV INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 329424 SEE SECTION H.10. 30382903294245

    Patients

    Seq Age Sex Outcome Treatment
    1