BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 8MM 90 BX 450 MO

    MDR report key: 11121796 · Received January 6, 2021

    Report

    Report Number
    1920898-2021-00005
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    December 9, 2020
    Report Date
    July 16, 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
    MA, US
    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: 2021-07-13 INVESTIGATION SUMMARY : CUSTOMER RETURNED (30) LOOSE 3/10CC, 8MM, 31G SYRINGES WITH A POLY BAG FROM LOT # 0090638. CUSTOMER STATES THAT WHEN THE SHIELD IS REMOVED, THE NEEDLE HUB SEPARATES. ALL RETURNED SYRINGES WERE EXAMINED AND 28 OUT OF 30 SAMPLES EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. 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 NOTED FOR OUT OF SPEC SHIELD PULL. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: BD WAS ABLE CONFIRM THE CUSTOMER¿S INDICATED FAILURE. 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. CAPA PR1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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 H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 0.3ML 8MM 90 BX 450 MO EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOUSE REPORTED, WHEN SHIELD IS REMOVED, NEEDLE HUB SEPARATES STATED, HE ADMINISTERS HIS WIFE'S SHOTS BECAUSE SHE HAS POOR VISION 2 SYRINGES AFFECTED LOT: 0090638, CATALOG: 328291, DATE OF EVENT: (B)(6) 2020.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 0.3ML 8MM 90 BX 450 MO EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOUSE REPORTED, WHEN SHIELD IS REMOVED, NEEDLE HUB SEPARATES STATED, HE ADMINISTERS HIS WIFE'S SHOTS BECAUSE SHE HAS POOR VISION 2 SYRINGES AFFECTED LOT: 0090638. CATALOG: 328291. DATE OF EVENT: (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    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 THE SYRINGE 0.3ML 8MM 90 BX 450 MO EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOUSE REPORTED, WHEN SHIELD IS REMOVED, NEEDLE HUB SEPARATES, STATED, HE ADMINISTERS HIS WIFE'S SHOTS BECAUSE SHE HAS POOR VISION, 2 SYRINGES AFFECTED, LOT: 0090638, CATALOG: 328291, DATE OF EVENT: (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19546 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