BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 8MM 90 BX 450 MO

    MDR report key: 11286676 · Received February 5, 2021

    Report

    Report Number
    1920898-2021-00154
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 14, 2021
    Report Date
    March 18, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282913
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2/9/2021. H.6. INVESTIGATION: TWO SYRINGES WERE RETURNED IN A 0.3ML 31 GAUGE 8MM SYRINGE POUCH FROM LOT # 0090638. BOTH SYRINGES WERE RETURNED FULLY INTACT. THE PLUNGER CAP WAS RETURNED WITH BOTH SYRINGES. EACH SYRINGE¿S NEEDLE SHIELD COULD BE REMOVED WITH SUFFICIENT EFFORT. THE SHIELD COULD BE REMOVED WITHOUT DAMAGING THE CONNECTION BETWEEN THE NEEDLE HUB AND BARREL. NO SIGNS OF USE OR DEFECTS OBSERVED. A NEEDLE SHIELD PULL FORCE TEST WAS PERFORMED ON BOTH SYRINGES. THESE NEEDLE SHIELDS REQUIRED 2.57 LBS AND 3.88 LBS OF FORCE TO BE REMOVED. THE SPECIFICATION STATES THAT ALL PULL FORCES WITHIN THE RANGE OF 0.85 LBS TO 5.95 LBS ARE ACCEPTABLE. WITH THE NEEDLE HUB ATTACHED AND THE NEEDLE SHIELD WITHIN SPECIFICATION, THE REPORT OF THE HUB SEPARATING FROM THE BARREL COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0090638 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200894508] NOTED FOR OUT OF SPEC SHIELD PULL. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 8MM 90 BX 450 MO NEEDLE HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328291. BATCH NO. 0090638. IT WAS REPORTED THAT NEEDLE HUB SEPARATED WHEN SHIELD WAS REMOVED AND THE NEEDLE SHIELD IS HARD TO REMOVE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 8MM 90 BX 450 MO NEEDLE HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328291, BATCH NO. 0090638. IT WAS REPORTED THAT NEEDLE HUB SEPARATED WHEN SHIELD WAS REMOVED AND THE NEEDLE SHIELD IS HARD TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182347 SYRINGE 0.3ML 8MM 90 BX 450 MO PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328291 0090638 00382903282913

    Patients

    Seq Age Sex Outcome Treatment
    1